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ARTICLE TITLE: Clinical Practice Guidelines on the Evidence-Based Use of Integrative Therapies During
and After Breast Cancer Treatment

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EDUCATIONAL OBJECTIVES:

ACTIVITY DISCLOSURES:
No commercial support has been accepted related to the development or publication of this activity.
ACS CONTINUING PROFESSIONAL EDUCATION COMMITTEE DISCLOSURES:
Editor: Ted Gansler, MD, MBA, MPH, has no financial relationships or interests to disclose.
Associate Editor: Durado Brooks, MD, MPH, has no financial relationships or interests to disclose.
Lead Nurse Planner: Cathy Meade, PhD, RN, FAAN, has no financial relationships or interests to disclose.
Editorial Advisory Member: Richard C. Wender, MD, has no financial relationships or interests to disclose.
NURSING ADVISORY BOARD DISCLOSURES:
Maureen Berg, RN, has no financial relationships or interests to disclose.
Susan Jackson, RN, MPH, has no financial relationships or interests to disclose.
Barbara Lesser, BSN, MSN, has no financial relationships or interests to disclose.
AUTHOR DISCLOSURES:
Linda E. Carlson, PhD, reports royalties from New Harbinger Publications and American Psychological Association Books, outside the submitted work. Misha R. Cohen,
OMD, LAc, reports royalties from Health Concerns Inc, outside the submitted work. Matthew Mumber, MD, reports ownership interest in the I Thrive cancer survivorship
software company, outside the submitted work.
Heather Greenlee, ND, PhD, MPH, Melissa J. DuPont-Reyes, MPH, MPhil, Lynda G. Balneaves, RN, PhD, Gary Deng, MD, PhD, Jillian A. Johnson, PhD, Dugald Seely, ND,
MSc, Suzanna Zick, ND, MPH, Lindsay M. Boyce, MLIS, and Debu Tripathy, MD, have no financial relationships or interests to disclose.

The peer reviewers disclose no conflicts of interest. Identities of the reviewers are not disclosed in line with the standard accepted practices of medical journal peer review.

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SPONSORED BY THE AMERICAN CANCER SOCIETY, INC.194 VOLUME 67 | NUMBER 3 | MAY/JUNE 2017

1. Highlight current practice guidelines on the use of integrative therapies during and after breast cancer treatment.
2. Apply evidence-based gradings of the efficacy of integrative treatment modalities that balance potential benefits and harms in formulating treatment decisions
and referrals for addressing the symptoms and side effects of breast cancer therapy.
3. Acknowledge the strengths and limitations of integrative therapies for treating breast cancer-related symptoms and side effects and future research needs in this area.

Clinical Practice Guidelines on the Evidence-Based Use of
Integrative Therapies During and After Breast Cancer

Treatment

Heather Greenlee, ND, PhD, MPH
1,2

; Melissa J. DuPont-Reyes, MPH, MPhil
3
; Lynda G. Balneaves, RN, PhD

4
;

Linda E. Carlson, PhD
5
; Misha R. Cohen, OMD, LAc

6,7
; Gary Deng, MD, PhD

8
; Jillian A. Johnson, PhD

9
; Matthew Mumber, MD

10
;

Dugald Seely, ND, MSc
11,12

; Suzanna M. Zick, ND, MPH
13,14

; Lindsay M. Boyce, MLIS
15

; Debu Tripathy, MD
16

Abstract: Patients with breast cancer commonly use complementary and integrative thera-
pies as supportive care during cancer treatment and to manage treatment-related side
effects. However, evidence supporting the use of such therapies in the oncology setting is
limited. This report provides updated clinical practice guidelines from the Society for Integra-
tive Oncology on the use of integrative therapies for specific clinical indications during and
after breast cancer treatment, including anxiety/stress, depression/mood disorders, fatigue,
quality of life/physical functioning, chemotherapy-induced nausea and vomiting, lymphede-
ma, chemotherapy-induced peripheral neuropathy, pain, and sleep disturbance. Clinical prac-
tice guidelines are based on a systematic literature review from 1990 through 2015. Music
therapy, meditation, stress management, and yoga are recommended for anxiety/stress
reduction. Meditation, relaxation, yoga, massage, and music therapy are recommended for
depression/mood disorders. Meditation and yoga are recommended to improve quality of
life. Acupressure and acupuncture are recommended for reducing chemotherapy-induced
nausea and vomiting. Acetyl-L-carnitine is not recommended to prevent chemotherapy-
induced peripheral neuropathy due to a possibility of harm. No strong evidence supports the
use of ingested dietary supplements to manage breast cancer treatment-related side effects.
In summary, there is a growing body of evidence supporting the use of integrative therapies,
especially mind-body therapies, as effective supportive care strategies during breast cancer
treatment. Many integrative practices, however, remain understudied, with insufficient evi-
dence to be definitively recommended or avoided. CA Cancer J Clin 2017;67:194-232.
VC 2017 American Cancer Society.

Keywords: acupressure, acupuncture, breast cancer, complementary therapies, integrative
medicine, integrative oncology, massage, meditation, music therapy, stress management, yoga

Practical Implications for Continuing Education

> To make informed decisions on the use of integrative therapies in the oncology
setting, clinicians and patients should understand the level of evidence of
associated benefits and harms for each therapy.

> Based on a systematic review of the literature, the Society for Integrative
Oncology makes the following recommendations:

– Use of music therapy, meditation, stress management and yoga for anxiety/
stress reduction.

– Use of meditation, relaxation, yoga, massage and music therapy for
depression/mood disorders.

– Use of meditation and yoga to improve quality of life.

– Use of acupressure and acupuncture for reducing CINV.

– There is a lack of strong evidence supporting the use of ingested dietary
supplements or botanical agents as supportive care and/or to manage breast
cancer treatment-related side effects.

> Implementing integrative therapies in a clinical setting requires a coordinated
team approach with well-trained providers. Training and credentialing for many
integrative providers varies by jurisdictions. Best practices suggest that
providers be trained to the highest standard of their profession and educated in
other relevant disciplines.

1
Assistant Professor, Department of

Epidemiology, Mailman School of Public
Health, Columbia University, New York, NY;
2
Member, Herbert Irving Comprehensive

Cancer Center, Columbia University, New
York, NY;

3
Doctoral Fellow, Department of

Epidemiology, Mailman School of Public
Health, Columbia University, New York, NY;
4
Associate Professor, College of Nursing,

Rady Faculty of Health Sciences, Winnipeg,
MB, Canada;

5
Professor, Department of

Oncology, University of Calgary, Calgary, AB,
Canada;

6
Adjunct Professor, American

College of Traditional Chinese Medicine at
California Institute of Integral Studies, San
Francisco, CA;

7
Clinic Director, Chicken Soup

Chinese Medicine, San Francisco, CA;
8
Medical Director, Integrative Oncology,

Memorial Sloan Kettering Cancer Center,
New York, NY;

9
Post-Doctoral Scholar,

Department of Biobehavioral Health, The
Pennsylvania State University, University
Park, PA;

10
Radiation Oncologist, Harbin

Clinic, Rome, GA;
11

Executive Director,
Ottawa Integrative Cancer Center, Ottawa,
ON, Canada;

12
Executive Director of

Research, Canadian College of Naturopathic
Medicine, Toronto, ON, Canada;

13
Research

Associate Professor, Department of Family
Medicine, Michigan Medicine, University of
Michigan, Ann Arbor, MI;

14
Research

Associate Professor, Department of
Nutritional Sciences, School of Public Health,
University of Michigan, Ann Arbor, MI;
15

Research Informationist, Memorial Sloan
Kettering Library, Memorial Sloan Kettering
Cancer Center, New York, NY;

16
Professor,

Department of Breast Medical Oncology, The
University of Texas MD Anderson Cancer
Center, Houston, TX.

Additional supporting information may be
found in the online version of this article.

Corresponding author: Heather Greenlee, ND,
PhD, MPH, Department of Epidemiology, Mailman
School of Public Health, Columbia University, 722
West 168th St, Seventh Fl, New York, NY 10032;
hg2120@columbia.edu

DISCLOSURES: Linda E. Carlson reports book
royalties from New Harbinger and the American
Psychological Association. Misha R. Cohen
reports royalties from Health Concerns Inc.,
outside the submitted work. Matthew Mumber
owns stock in I Thrive. All remaining authors
report no conflicts of interest.

doi: 10.3322/caac.21397. Available online
at cacancerjournal.com

VOLUME 67 _ NUMBER 3 _ MAY/JUNE 2017 195

CA CANCER J CLIN 2017;67:194–232

Introduction

Patients with breast cancer and breast cancer survivors are

frequent users of complementary and integrative therapies,

and there are growing numbers of formal, integrative oncol-

ogy programs within cancer centers.
1-6

Various terms are

used to describe such therapies, and it is helpful at the outset

to define terms. Complementary and alternative therapies are

generally defined as any medical system, practice, or product

that is not part of conventional medical care.7,8 Other rele-

vant terminology includes complementary medicine, which

comprises therapies used as a complement alongside

conventional medicine; alternative medicine, which com-

prises therapies used in place of conventional medicine; and

integrative medicine, which is the coordinated use of

evidence-based complementary practices and conventional

care. Integrative oncology refers to the use of complementary

and integrative therapies in collaboration with conventional

oncology care. In oncology, individuals use complementary

and integrative therapies with the intent of enhancing

wellness, improving quality of life (QOL), and relieving

symptoms of disease and side effects of conventional treat-

ments. However, the evidence supporting the use of

complementary and integrative therapies in the oncology

setting is limited.

In November 2014, the Society for Integrative Oncology

(SIO) published clinical practice guidelines to inform both

clinicians and patients on the use of integrative therapies

during breast cancer treatment and to treat breast cancer

treatment-related symptoms.9 The SIO adapted methods

established by the US Preventive Services Task Force10 to

develop graded recommendations on the use of specific inte-

grative therapies for defined clinical indications based on

the strength of available evidence concerning associated

benefits and harms. The 2014 clinical practice guidelines

were derived from a systematic review of randomized clini-

cal trials published between 1990 and 2013 and organized

by specific clinical conditions (eg, anxiety/stress, fatigue).

This review provides an updated set of clinical practice

guidelines based on a current, systematic literature review of

randomized controlled trials (RCTs) published through

December 2015 along with detailed definitions of integra-

tive therapies and clinical outcomes of interest, a detailed

summary of the literature upon which the clinical practice

guidelines are based, and suggestions for how appropriate

therapies may be integrated into clinical practice.

Of note, it is important to define the use of the term rec-

ommendation in these clinical practice guidelines. In many

settings, a clinical guideline recommendation suggests that it

should be used as the standard of care and is favorable or

equal compared with all other options based on best clinical

evidence for benefit/risk ratio. Here, in the setting of inte-

grative oncology, we use the term recommendation to

conclude that the therapy should be considered as a viable

but not singular option for the management of a specific

symptom or side effect. Few studies have conducted a head-

to-head comparison of a given integrative therapy against a

conventional treatment, and most integrative therapies are

used in conjunction with standard therapy and have been

studied in this manner. Moreover, combination-based

approaches and the interactions of the numerous permuta-

tions of integrative and conventional treatments have not

been formally investigated, such that recommendations must

account for this limitation of our knowledge. Despite these

limitations to evaluating the use of integrative therapies in

the oncology setting, there is a body of well conducted trials

of specific therapies for specific conditions that provides suf-

ficient evidence to warrant recommendations on the thera-

pies as viable options for treating specific conditions.

In this review, we provide clinicians and patients with

updated SIO clinical practice guidelines on the use of inte-

grative therapies to manage symptoms and side effects during

and after breast cancer treatment. The clinical practice guide-

lines do not address breast cancer recurrence or survival end-

points, because very few adequately powered RCTs have

examined the effect of integrative therapies on these out-

comes. We also provide a definition for each integrative ther-

apy that had a sufficiently large body of evidence to formulate

a specific recommendation. Information is also provided on

how to implement the recommendations into the clinical set-

ting, with caveats for specific clinical situations. In addition,

this review summarizes pertinent meta-analyses and identifies

promising areas for future investigation. The information

that arose from other published reviews and meta-analyses

did not change the interpretation of the findings or the quali-

ty of specific trials, but the information was used to influence

the establishment of specific recommendation grades based

on consistency, reproducibility, and assessment of potential

harms and benefits. The goal of this current review is to pro-

vide clinicians and patients with practical information and

tools to evaluate whether there is an evidence base to support

the use of a defined integrative therapy for a specific clinical

application in the context of breast cancer.

Methods

Systematic Review Methodology

To update the previously published clinical practice guide-

lines, which were based on a systematic review of the litera-

ture from January 1, 1990 through December 31, 2013,
9

we

conducted a systematic review of published RCTs from Jan-

uary 1, 2014 through December 31, 2015, using the same

search criteria and process. The process followed the meth-

ods set forth by the Institute of Medicine on clinical guide-

line development.
11

The following databases were searched:

Embase, MEDLINE, PsychINFO, and CINAHL.

Integrative Therapies During and After Breast Cancer Treatment

196 CA: A Cancer Journal for Clinicians

As previously reported,9 trials were selected for inclusion in

the systematic review if they met the following criteria:

1) peer-reviewed, published RCT; 2) available in English;

3) included �50% patients with breast cancer and/or
reported results separately for patients with breast cancer;

4) used an integrative therapy as an intervention during stan-

dard treatment with surgery, chemotherapy, radiation thera-

py, and/or hormonal therapy or addressed symptoms and

side effects resulting from diagnosis and/or treatment; and

5) addressed an endpoint of clinical relevance to patients

with breast cancer and breast cancer survivors (see Support-

ing Information Table 1).9 Several lifestyle and psychological

interventions were excluded from current as well as previous

guidelines, because they have already been well summarized

by other groups (eg, diet
12,13

and physical activity
12-14

rec-

ommendations for cancer survivors) and/or because they

have a strong evidence base and are often considered to be

mainstream rather than integrative or complementary (eg,

cognitive-behavioral therapy,
15

psychoeducation,
16

counsel-

ing,
17

and support groups
16

). Other interventions that were

excluded were in early or pilot stages of research (eg,

attention-restoration therapy) or were not considered to be

an integrative oncology therapy for the purposes of the SIO

guidelines (eg, prayer, spirituality). Each article was scored

according to the quality of design and reporting based on the

Jadad scoring scale and a modified scale adapted from the

Delphi scoring system.18,19 Finally, grades of evidence were

determined for each therapy as applied to a specific clinical

outcome using a modified version of the US Preventive Serv-

ices Task Force grading system.
10

Grades were based on

strength of evidence, determined by the number of trials,

quality of trials, magnitude of effect, statistical significance,

sample size, consistency of results across studies, and whether

the outcomes were primary or secondary. The highest grades

(A and B) indicate that a specific therapy is recommended for

a particular clinical indication. Grade A indicates there is

high certainty that the net benefit is substantial, while grade

B indicates there is high certainty that the net benefit is mod-

erate or there is moderate certainty that the net benefit is

moderate to substantial. Grade C indicates that the evidence

is equivocal or that there is at least moderate certainty that

the net benefit is small. The lowest grades (D, H, and I) indi-

cate no demonstrated effect, suggest harm, or indicate that

the current evidence is inconclusive, respectively.

According to the clinical guideline development process

outlined by the Institute of Medicine,11 drafts prepared by

the SIO Guideline Working Group were distributed to an

interdisciplinary group of SIO internal and external reviewers.

Reviewer comments, suggestions, and critiques were incorpo-

rated into the final version of these guidelines.

It is important to note that, as we reviewed the literature,

we recognized the difference between statistical and

clinical significance. The graded recommendations reflect

our assessment of the clinical significance based on our

assessment of the body of literature, including the impor-

tance of statistical significance with respect to the primary

endpoint. We did not report on specific magnitudes of

effect because of the range of outcome measures and statisti-

cal methods used across the trials, which made it difficult to

describe detailed data on effect sizes across all trials.

Although some of the trials with small sample sizes (n <

100) may have been methodologically sound, we down-

played their contribution to the graded recommendation,

because larger trials provided more information on general-

izability of results to larger populations. Because of space

limitations, P values are reported and citations are provided

to reference the primary reports for additional details.

Definitions of Complementary and Integrative
Therapies

Below are definitions listed alphabetically for each of the

complementary and integrative therapies that received

a grade of A, B, C, D, or H in the updated clinical

practice guidelines.20,21 Table 1 displays the graded rec-

ommendations.
10,22-151

Table 2 provides background

information on the specific training, licensure, and profes-

sional organizations associated with each therapy.152 If a

therapy is known to have a specific contraindication or

caution, it is noted in the description. The descriptions

include statements on how the therapies are often used by

patients with cancer and by survivors but do not indicate

the level of evidence supporting such use. The guideline

recommendations provide a summary of the evidence on

the use for specific conditions. In addition to the informa-

tion provided below, there are continuously updated, well

referenced websites that can provide additional details on

the range of therapies, including Natural Medicines (nat-

uralmedicines.therapeuticresearch.com), Memorial Sloan

Kettering Cancer Center’s About Herbs website (mskcc.org/

cancer-care/treatments/symptom-management/integrative-

medicine/herbs), and the National Cancer Institute (NCI)

Office of Cancer Complementary and Alternative Medicine

Therapies: A-Z website (cam.cancer.gov/health_informa-

tion/cam_therapies_a-z.htm).

Acetyl-L-carnitine

Acetyl-L-carnitine is a dietary supplement that some

patients use to treat cancer-related fatigue by enhancing

energy and lowering inflammation in the body.
153

It has

demonstrated effectiveness in preventing and treating dia-

betic neuropathy and thus was of interest to examine in the

context of chemotherapy-induced peripheral neuropathy

(CIPN). It is a substance made in muscle and liver tissue

and is found in foods, including meats, poultry, fish, and

some dairy products.

CA CANCER J CLIN 2017;67:194–232

VOLUME 67 _ NUMBER 3 _ MAY/JUNE 2017 197

TABLE 1. Graded Integrative Therapies for Use in Patients With Breast Cancer According to Clinical Outcomes
a

CLINICAL
OUTCOMES RECOMMENDED THERAPY

STRENGTH OF
EVIDENCE GRADEb

Acute radiation
skin reaction

Aloe vera22,23 and hyaluronic acid cream24,25 should not be recommended for improving acute
radiation skin reaction.

D

Anxiety/stress reduction Meditation is recommended for reducing anxiety.26-30 A

Music therapy is recommended for reducing anxiety.31-35 B

Stress management is recommended for reducing anxiety during treatment, but longer group
programs are likely better than self-administered home programs or shorter programs.36-39

B

Yoga is recommended for reducing anxiety.40-48 B

Acupuncture,49-51 massage,52-55 and relaxation56-60 can be considered for reducing anxiety. C

Chemotherapy-induced
nausea and vomiting

Acupressure can be considered as an addition to antiemetics drugs to control nausea and
vomiting during chemotherapy.61-63

B

Electroacupuncture can be considered as an addition to antiemetics drugs to control vomiting
during chemotherapy.64,65

B

Ginger66-68 and relaxation59,69 can be considered as additions to antiemetic drugs to control
nausea and vomiting during chemotherapy.

C

Glutamine70,71 should not be recommended for improving nausea and vomiting during
chemotherapy.

D

Depression/mood
disturbance

Meditation, particularly MBSR, is recommended for treating mood disturbance and depressive
symptoms.26-30,72-76

A

Relaxation is recommended for improving mood disturbance and depressive
symptoms.56,59,60,69,77,78

A

Yoga is recommended for improving mood and depressive symptoms.40-43,45-48,79-85 B

Massage is recommended for improving mood disturbance.53-55,86-88 B

Music therapy is recommended for improving mood.33,35,89,90 B

Acupuncture,49-51,91,92 healing touch,93,94 and stress management36-38,95,96 can be considered
for improving mood disturbance and depressive symptoms.

C

Fatigue Hypnosis97,98 and ginseng99,100 can be considered for improving fatigue during treatment. C

Acupuncture51,101-103 and yoga45,80,84,104-106 can be considered for improving post-treatment
fatigue.

C

Acetyl-L-carnitine107 and guarana108,109 should not be recommended for improving fatigue
during treatment.

D

Lymphedema Low-level laser therapy,110,111 manual lymphatic drainage,112-118 and compression bandag-
ing114-116 can be considered for improving lymphedema.

C

Neuropathy Acetyl-L-carnitine is not recommended for the prevention of chemotherapy-induced peripheral
neuropathy in patients with BC due to potential harm.107

H

Pain Acupuncture,119-124 healing touch,93 hypnosis,125,126 and music therapy31,34 can be considered
for the management of pain.

C

Quality of life Meditation is recommended for improving quality of life.27-29,73-75,127 A

Yoga is recommended for improving quality of life.43,46-48,82-85,104-106,128 B

Acupuncture,49,51,102,129,130 mistletoe,131-134 qigong,135,136 reflexology,137-139 and stress
management36-38,95,96,140,141 can be considered for improving quality of life.

C

Sleep disturbance Gentle yoga45,48,79,84,142 can be considered for improving sleep. C

Vasomotor/hot flashes Acupuncture49,91,92,143-148 can be considered for improving hot flashes. C

Soy149-151 is not recommended for hot flashes in patients with BC due to lack of effect. D

Abbreviations: BC, breast cancer; MBSR, mindfulness-based stress reduction.

need help revising my evidence based guidelines article review

Take free quizzes online at acsjournals.com/ce

ONLINE CONTINUING EDUCATION ACTIVITY

After reading the article “Clinical Practice Guidelines on the Evidence-Based Use of Integrative Therapies During and After Breast Cancer Treatment,” the learner
should be able to:

ARTICLE TITLE: Clinical Practice Guidelines on the Evidence-Based Use of Integrative Therapies During
and After Breast Cancer Treatment

CONTINUING MEDICAL EDUCATION ACCREDITATION AND DESIGNATION STATEMENT:
Blackwell Futura Media Services is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education (CME)
for physicians.
Blackwell Futura Media Services designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credit™. Physicians should only claim credit
commensurate with the extent of their participation in the activity.

CONTINUING NURSING EDUCATION ACCREDITATION AND DESIGNATION STATEMENT:
The American Cancer Society (ACS) is accredited as a provider of continuing nursing education (CNE) by the American Nurses Credentialing Center’s Commission on
Accreditation.
Accredited status does not imply endorsement by the ACS or the American Nurses Credentialing Center of any commercial products displayed or discussed in
conjunction with an educational activity. The ACS gratefully acknowledges the sponsorship provided by Wiley for hosting these CNE activities.
EDUCATIONAL OBJECTIVES:

ACTIVITY DISCLOSURES:
No commercial support has been accepted related to the development or publication of this activity.
ACS CONTINUING PROFESSIONAL EDUCATION COMMITTEE DISCLOSURES:
Editor: Ted Gansler, MD, MBA, MPH, has no financial relationships or interests to disclose.
Associate Editor: Durado Brooks, MD, MPH, has no financial relationships or interests to disclose.
Lead Nurse Planner: Cathy Meade, PhD, RN, FAAN, has no financial relationships or interests to disclose.
Editorial Advisory Member: Richard C. Wender, MD, has no financial relationships or interests to disclose.
NURSING ADVISORY BOARD DISCLOSURES:
Maureen Berg, RN, has no financial relationships or interests to disclose.
Susan Jackson, RN, MPH, has no financial relationships or interests to disclose.
Barbara Lesser, BSN, MSN, has no financial relationships or interests to disclose.
AUTHOR DISCLOSURES:
Linda E. Carlson, PhD, reports royalties from New Harbinger Publications and American Psychological Association Books, outside the submitted work. Misha R. Cohen,
OMD, LAc, reports royalties from Health Concerns Inc, outside the submitted work. Matthew Mumber, MD, reports ownership interest in the I Thrive cancer survivorship
software company, outside the submitted work.
Heather Greenlee, ND, PhD, MPH, Melissa J. DuPont-Reyes, MPH, MPhil, Lynda G. Balneaves, RN, PhD, Gary Deng, MD, PhD, Jillian A. Johnson, PhD, Dugald Seely, ND,
MSc, Suzanna Zick, ND, MPH, Lindsay M. Boyce, MLIS, and Debu Tripathy, MD, have no financial relationships or interests to disclose.

The peer reviewers disclose no conflicts of interest. Identities of the reviewers are not disclosed in line with the standard accepted practices of medical journal peer review.

CNECME

SCORING:
A score of 70% or better is needed to pass a quiz containing 10 questions (7 correct answers), or 80% or better for 5 questions (4 correct answers).

INSTRUCTIONS ON RECEIVING CME CREDIT:
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licensing board.

This activity is designed to be completed within 2.25 hours; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully
earn credit, participants must complete the activity during the valid credit period, which is up to 2 years from the time of initial publication.

CME

INSTRUCTIONS ON RECEIVING CNE CREDIT:
This activity is intended for nurses. For information concerning the applicability and acceptance of CNE credit for this activity, please consult your professional
licensing board.

This activity is designed to be completed within 2.25 hours; nurses should claim only those credits that reflect the time actually spent in the activity. To successfully
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FOLLOW THESE STEPS TO EARN CREDIT:
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• Reflect on the activity contents.
• Access the examination, and choose the best answer to each question.
• Complete the required evaluation component of the activity.
• Claim your certificate.

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SPONSORED BY THE AMERICAN CANCER SOCIETY, INC.194 VOLUME 67 | NUMBER 3 | MAY/JUNE 2017

1. Highlight current practice guidelines on the use of integrative therapies during and after breast cancer treatment.
2. Apply evidence-based gradings of the efficacy of integrative treatment modalities that balance potential benefits and harms in formulating treatment decisions
and referrals for addressing the symptoms and side effects of breast cancer therapy.
3. Acknowledge the strengths and limitations of integrative therapies for treating breast cancer-related symptoms and side effects and future research needs in this area.

Clinical Practice Guidelines on the Evidence-Based Use of
Integrative Therapies During and After Breast Cancer

Treatment

Heather Greenlee, ND, PhD, MPH
1,2

; Melissa J. DuPont-Reyes, MPH, MPhil
3
; Lynda G. Balneaves, RN, PhD

4
;

Linda E. Carlson, PhD
5
; Misha R. Cohen, OMD, LAc

6,7
; Gary Deng, MD, PhD

8
; Jillian A. Johnson, PhD

9
; Matthew Mumber, MD

10
;

Dugald Seely, ND, MSc
11,12

; Suzanna M. Zick, ND, MPH
13,14

; Lindsay M. Boyce, MLIS
15

; Debu Tripathy, MD
16

Abstract: Patients with breast cancer commonly use complementary and integrative thera-
pies as supportive care during cancer treatment and to manage treatment-related side
effects. However, evidence supporting the use of such therapies in the oncology setting is
limited. This report provides updated clinical practice guidelines from the Society for Integra-
tive Oncology on the use of integrative therapies for specific clinical indications during and
after breast cancer treatment, including anxiety/stress, depression/mood disorders, fatigue,
quality of life/physical functioning, chemotherapy-induced nausea and vomiting, lymphede-
ma, chemotherapy-induced peripheral neuropathy, pain, and sleep disturbance. Clinical prac-
tice guidelines are based on a systematic literature review from 1990 through 2015. Music
therapy, meditation, stress management, and yoga are recommended for anxiety/stress
reduction. Meditation, relaxation, yoga, massage, and music therapy are recommended for
depression/mood disorders. Meditation and yoga are recommended to improve quality of
life. Acupressure and acupuncture are recommended for reducing chemotherapy-induced
nausea and vomiting. Acetyl-L-carnitine is not recommended to prevent chemotherapy-
induced peripheral neuropathy due to a possibility of harm. No strong evidence supports the
use of ingested dietary supplements to manage breast cancer treatment-related side effects.
In summary, there is a growing body of evidence supporting the use of integrative therapies,
especially mind-body therapies, as effective supportive care strategies during breast cancer
treatment. Many integrative practices, however, remain understudied, with insufficient evi-
dence to be definitively recommended or avoided. CA Cancer J Clin 2017;67:194-232.
VC 2017 American Cancer Society.

Keywords: acupressure, acupuncture, breast cancer, complementary therapies, integrative
medicine, integrative oncology, massage, meditation, music therapy, stress management, yoga

Practical Implications for Continuing Education

> To make informed decisions on the use of integrative therapies in the oncology
setting, clinicians and patients should understand the level of evidence of
associated benefits and harms for each therapy.

> Based on a systematic review of the literature, the Society for Integrative
Oncology makes the following recommendations:

– Use of music therapy, meditation, stress management and yoga for anxiety/
stress reduction.

– Use of meditation, relaxation, yoga, massage and music therapy for
depression/mood disorders.

– Use of meditation and yoga to improve quality of life.

– Use of acupressure and acupuncture for reducing CINV.

– There is a lack of strong evidence supporting the use of ingested dietary
supplements or botanical agents as supportive care and/or to manage breast
cancer treatment-related side effects.

> Implementing integrative therapies in a clinical setting requires a coordinated
team approach with well-trained providers. Training and credentialing for many
integrative providers varies by jurisdictions. Best practices suggest that
providers be trained to the highest standard of their profession and educated in
other relevant disciplines.

1
Assistant Professor, Department of

Epidemiology, Mailman School of Public
Health, Columbia University, New York, NY;
2
Member, Herbert Irving Comprehensive

Cancer Center, Columbia University, New
York, NY;

3
Doctoral Fellow, Department of

Epidemiology, Mailman School of Public
Health, Columbia University, New York, NY;
4
Associate Professor, College of Nursing,

Rady Faculty of Health Sciences, Winnipeg,
MB, Canada;

5
Professor, Department of

Oncology, University of Calgary, Calgary, AB,
Canada;

6
Adjunct Professor, American

College of Traditional Chinese Medicine at
California Institute of Integral Studies, San
Francisco, CA;

7
Clinic Director, Chicken Soup

Chinese Medicine, San Francisco, CA;
8
Medical Director, Integrative Oncology,

Memorial Sloan Kettering Cancer Center,
New York, NY;

9
Post-Doctoral Scholar,

Department of Biobehavioral Health, The
Pennsylvania State University, University
Park, PA;

10
Radiation Oncologist, Harbin

Clinic, Rome, GA;
11

Executive Director,
Ottawa Integrative Cancer Center, Ottawa,
ON, Canada;

12
Executive Director of

Research, Canadian College of Naturopathic
Medicine, Toronto, ON, Canada;

13
Research

Associate Professor, Department of Family
Medicine, Michigan Medicine, University of
Michigan, Ann Arbor, MI;

14
Research

Associate Professor, Department of
Nutritional Sciences, School of Public Health,
University of Michigan, Ann Arbor, MI;
15

Research Informationist, Memorial Sloan
Kettering Library, Memorial Sloan Kettering
Cancer Center, New York, NY;

16
Professor,

Department of Breast Medical Oncology, The
University of Texas MD Anderson Cancer
Center, Houston, TX.

Additional supporting information may be
found in the online version of this article.

Corresponding author: Heather Greenlee, ND,
PhD, MPH, Department of Epidemiology, Mailman
School of Public Health, Columbia University, 722
West 168th St, Seventh Fl, New York, NY 10032;
hg2120@columbia.edu

DISCLOSURES: Linda E. Carlson reports book
royalties from New Harbinger and the American
Psychological Association. Misha R. Cohen
reports royalties from Health Concerns Inc.,
outside the submitted work. Matthew Mumber
owns stock in I Thrive. All remaining authors
report no conflicts of interest.

doi: 10.3322/caac.21397. Available online
at cacancerjournal.com

VOLUME 67 _ NUMBER 3 _ MAY/JUNE 2017 195

CA CANCER J CLIN 2017;67:194–232

Introduction

Patients with breast cancer and breast cancer survivors are

frequent users of complementary and integrative therapies,

and there are growing numbers of formal, integrative oncol-

ogy programs within cancer centers.
1-6

Various terms are

used to describe such therapies, and it is helpful at the outset

to define terms. Complementary and alternative therapies are

generally defined as any medical system, practice, or product

that is not part of conventional medical care.7,8 Other rele-

vant terminology includes complementary medicine, which

comprises therapies used as a complement alongside

conventional medicine; alternative medicine, which com-

prises therapies used in place of conventional medicine; and

integrative medicine, which is the coordinated use of

evidence-based complementary practices and conventional

care. Integrative oncology refers to the use of complementary

and integrative therapies in collaboration with conventional

oncology care. In oncology, individuals use complementary

and integrative therapies with the intent of enhancing

wellness, improving quality of life (QOL), and relieving

symptoms of disease and side effects of conventional treat-

ments. However, the evidence supporting the use of

complementary and integrative therapies in the oncology

setting is limited.

In November 2014, the Society for Integrative Oncology

(SIO) published clinical practice guidelines to inform both

clinicians and patients on the use of integrative therapies

during breast cancer treatment and to treat breast cancer

treatment-related symptoms.9 The SIO adapted methods

established by the US Preventive Services Task Force10 to

develop graded recommendations on the use of specific inte-

grative therapies for defined clinical indications based on

the strength of available evidence concerning associated

benefits and harms. The 2014 clinical practice guidelines

were derived from a systematic review of randomized clini-

cal trials published between 1990 and 2013 and organized

by specific clinical conditions (eg, anxiety/stress, fatigue).

This review provides an updated set of clinical practice

guidelines based on a current, systematic literature review of

randomized controlled trials (RCTs) published through

December 2015 along with detailed definitions of integra-

tive therapies and clinical outcomes of interest, a detailed

summary of the literature upon which the clinical practice

guidelines are based, and suggestions for how appropriate

therapies may be integrated into clinical practice.

Of note, it is important to define the use of the term rec-

ommendation in these clinical practice guidelines. In many

settings, a clinical guideline recommendation suggests that it

should be used as the standard of care and is favorable or

equal compared with all other options based on best clinical

evidence for benefit/risk ratio. Here, in the setting of inte-

grative oncology, we use the term recommendation to

conclude that the therapy should be considered as a viable

but not singular option for the management of a specific

symptom or side effect. Few studies have conducted a head-

to-head comparison of a given integrative therapy against a

conventional treatment, and most integrative therapies are

used in conjunction with standard therapy and have been

studied in this manner. Moreover, combination-based

approaches and the interactions of the numerous permuta-

tions of integrative and conventional treatments have not

been formally investigated, such that recommendations must

account for this limitation of our knowledge. Despite these

limitations to evaluating the use of integrative therapies in

the oncology setting, there is a body of well conducted trials

of specific therapies for specific conditions that provides suf-

ficient evidence to warrant recommendations on the thera-

pies as viable options for treating specific conditions.

In this review, we provide clinicians and patients with

updated SIO clinical practice guidelines on the use of inte-

grative therapies to manage symptoms and side effects during

and after breast cancer treatment. The clinical practice guide-

lines do not address breast cancer recurrence or survival end-

points, because very few adequately powered RCTs have

examined the effect of integrative therapies on these out-

comes. We also provide a definition for each integrative ther-

apy that had a sufficiently large body of evidence to formulate

a specific recommendation. Information is also provided on

how to implement the recommendations into the clinical set-

ting, with caveats for specific clinical situations. In addition,

this review summarizes pertinent meta-analyses and identifies

promising areas for future investigation. The information

that arose from other published reviews and meta-analyses

did not change the interpretation of the findings or the quali-

ty of specific trials, but the information was used to influence

the establishment of specific recommendation grades based

on consistency, reproducibility, and assessment of potential

harms and benefits. The goal of this current review is to pro-

vide clinicians and patients with practical information and

tools to evaluate whether there is an evidence base to support

the use of a defined integrative therapy for a specific clinical

application in the context of breast cancer.

Methods

Systematic Review Methodology

To update the previously published clinical practice guide-

lines, which were based on a systematic review of the litera-

ture from January 1, 1990 through December 31, 2013,
9

we

conducted a systematic review of published RCTs from Jan-

uary 1, 2014 through December 31, 2015, using the same

search criteria and process. The process followed the meth-

ods set forth by the Institute of Medicine on clinical guide-

line development.
11

The following databases were searched:

Embase, MEDLINE, PsychINFO, and CINAHL.

Integrative Therapies During and After Breast Cancer Treatment

196 CA: A Cancer Journal for Clinicians

As previously reported,9 trials were selected for inclusion in

the systematic review if they met the following criteria:

1) peer-reviewed, published RCT; 2) available in English;

3) included �50% patients with breast cancer and/or
reported results separately for patients with breast cancer;

4) used an integrative therapy as an intervention during stan-

dard treatment with surgery, chemotherapy, radiation thera-

py, and/or hormonal therapy or addressed symptoms and

side effects resulting from diagnosis and/or treatment; and

5) addressed an endpoint of clinical relevance to patients

with breast cancer and breast cancer survivors (see Support-

ing Information Table 1).9 Several lifestyle and psychological

interventions were excluded from current as well as previous

guidelines, because they have already been well summarized

by other groups (eg, diet
12,13

and physical activity
12-14

rec-

ommendations for cancer survivors) and/or because they

have a strong evidence base and are often considered to be

mainstream rather than integrative or complementary (eg,

cognitive-behavioral therapy,
15

psychoeducation,
16

counsel-

ing,
17

and support groups
16

). Other interventions that were

excluded were in early or pilot stages of research (eg,

attention-restoration therapy) or were not considered to be

an integrative oncology therapy for the purposes of the SIO

guidelines (eg, prayer, spirituality). Each article was scored

according to the quality of design and reporting based on the

Jadad scoring scale and a modified scale adapted from the

Delphi scoring system.18,19 Finally, grades of evidence were

determined for each therapy as applied to a specific clinical

outcome using a modified version of the US Preventive Serv-

ices Task Force grading system.
10

Grades were based on

strength of evidence, determined by the number of trials,

quality of trials, magnitude of effect, statistical significance,

sample size, consistency of results across studies, and whether

the outcomes were primary or secondary. The highest grades

(A and B) indicate that a specific therapy is recommended for

a particular clinical indication. Grade A indicates there is

high certainty that the net benefit is substantial, while grade

B indicates there is high certainty that the net benefit is mod-

erate or there is moderate certainty that the net benefit is

moderate to substantial. Grade C indicates that the evidence

is equivocal or that there is at least moderate certainty that

the net benefit is small. The lowest grades (D, H, and I) indi-

cate no demonstrated effect, suggest harm, or indicate that

the current evidence is inconclusive, respectively.

According to the clinical guideline development process

outlined by the Institute of Medicine,11 drafts prepared by

the SIO Guideline Working Group were distributed to an

interdisciplinary group of SIO internal and external reviewers.

Reviewer comments, suggestions, and critiques were incorpo-

rated into the final version of these guidelines.

It is important to note that, as we reviewed the literature,

we recognized the difference between statistical and

clinical significance. The graded recommendations reflect

our assessment of the clinical significance based on our

assessment of the body of literature, including the impor-

tance of statistical significance with respect to the primary

endpoint. We did not report on specific magnitudes of

effect because of the range of outcome measures and statisti-

cal methods used across the trials, which made it difficult to

describe detailed data on effect sizes across all trials.

Although some of the trials with small sample sizes (n <

100) may have been methodologically sound, we down-

played their contribution to the graded recommendation,

because larger trials provided more information on general-

izability of results to larger populations. Because of space

limitations, P values are reported and citations are provided

to reference the primary reports for additional details.

Definitions of Complementary and Integrative
Therapies

Below are definitions listed alphabetically for each of the

complementary and integrative therapies that received

a grade of A, B, C, D, or H in the updated clinical

practice guidelines.20,21 Table 1 displays the graded rec-

ommendations.
10,22-151

Table 2 provides background

information on the specific training, licensure, and profes-

sional organizations associated with each therapy.152 If a

therapy is known to have a specific contraindication or

caution, it is noted in the description. The descriptions

include statements on how the therapies are often used by

patients with cancer and by survivors but do not indicate

the level of evidence supporting such use. The guideline

recommendations provide a summary of the evidence on

the use for specific conditions. In addition to the informa-

tion provided below, there are continuously updated, well

referenced websites that can provide additional details on

the range of therapies, including Natural Medicines (nat-

uralmedicines.therapeuticresearch.com), Memorial Sloan

Kettering Cancer Center’s About Herbs website (mskcc.org/

cancer-care/treatments/symptom-management/integrative-

medicine/herbs), and the National Cancer Institute (NCI)

Office of Cancer Complementary and Alternative Medicine

Therapies: A-Z website (cam.cancer.gov/health_informa-

tion/cam_therapies_a-z.htm).

Acetyl-L-carnitine

Acetyl-L-carnitine is a dietary supplement that some

patients use to treat cancer-related fatigue by enhancing

energy and lowering inflammation in the body.
153

It has

demonstrated effectiveness in preventing and treating dia-

betic neuropathy and thus was of interest to examine in the

context of chemotherapy-induced peripheral neuropathy

(CIPN). It is a substance made in muscle and liver tissue

and is found in foods, including meats, poultry, fish, and

some dairy products.

CA CANCER J CLIN 2017;67:194–232

VOLUME 67 _ NUMBER 3 _ MAY/JUNE 2017 197

TABLE 1. Graded Integrative Therapies for Use in Patients With Breast Cancer According to Clinical Outcomes
a

CLINICAL
OUTCOMES RECOMMENDED THERAPY

STRENGTH OF
EVIDENCE GRADEb

Acute radiation
skin reaction

Aloe vera22,23 and hyaluronic acid cream24,25 should not be recommended for improving acute
radiation skin reaction.

D

Anxiety/stress reduction Meditation is recommended for reducing anxiety.26-30 A

Music therapy is recommended for reducing anxiety.31-35 B

Stress management is recommended for reducing anxiety during treatment, but longer group
programs are likely better than self-administered home programs or shorter programs.36-39

B

Yoga is recommended for reducing anxiety.40-48 B

Acupuncture,49-51 massage,52-55 and relaxation56-60 can be considered for reducing anxiety. C

Chemotherapy-induced
nausea and vomiting

Acupressure can be considered as an addition to antiemetics drugs to control nausea and
vomiting during chemotherapy.61-63

B

Electroacupuncture can be considered as an addition to antiemetics drugs to control vomiting
during chemotherapy.64,65

B

Ginger66-68 and relaxation59,69 can be considered as additions to antiemetic drugs to control
nausea and vomiting during chemotherapy.

C

Glutamine70,71 should not be recommended for improving nausea and vomiting during
chemotherapy.

D

Depression/mood
disturbance

Meditation, particularly MBSR, is recommended for treating mood disturbance and depressive
symptoms.26-30,72-76

A

Relaxation is recommended for improving mood disturbance and depressive
symptoms.56,59,60,69,77,78

A

Yoga is recommended for improving mood and depressive symptoms.40-43,45-48,79-85 B

Massage is recommended for improving mood disturbance.53-55,86-88 B

Music therapy is recommended for improving mood.33,35,89,90 B

Acupuncture,49-51,91,92 healing touch,93,94 and stress management36-38,95,96 can be considered
for improving mood disturbance and depressive symptoms.

C

Fatigue Hypnosis97,98 and ginseng99,100 can be considered for improving fatigue during treatment. C

Acupuncture51,101-103 and yoga45,80,84,104-106 can be considered for improving post-treatment
fatigue.

C

Acetyl-L-carnitine107 and guarana108,109 should not be recommended for improving fatigue
during treatment.

D

Lymphedema Low-level laser therapy,110,111 manual lymphatic drainage,112-118 and compression bandag-
ing114-116 can be considered for improving lymphedema.

C

Neuropathy Acetyl-L-carnitine is not recommended for the prevention of chemotherapy-induced peripheral
neuropathy in patients with BC due to potential harm.107

H

Pain Acupuncture,119-124 healing touch,93 hypnosis,125,126 and music therapy31,34 can be considered
for the management of pain.

C

Quality of life Meditation is recommended for improving quality of life.27-29,73-75,127 A

Yoga is recommended for improving quality of life.43,46-48,82-85,104-106,128 B

Acupuncture,49,51,102,129,130 mistletoe,131-134 qigong,135,136 reflexology,137-139 and stress
management36-38,95,96,140,141 can be considered for improving quality of life.

C

Sleep disturbance Gentle yoga45,48,79,84,142 can be considered for improving sleep. C

Vasomotor/hot flashes Acupuncture49,91,92,143-148 can be considered for improving hot flashes. C

Soy149-151 is not recommended for hot flashes in patients with BC due to lack of effect. D

Abbreviations: BC, breast cancer; MBSR, mindfulness-based stress reduction.

need help revising my evidence based guidelines article review

World Journal of
Meta-Analysis

World J Meta-Anal 2019 November 28; 7(9): 406-435

ISSN 2308-3840 (online)

Published by Baishideng Publishing Group Inc

W J M A
World Journal of
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Contents Irregular Volume 7 Number 9 November 28, 2019

REVIEW
406 Treatment of early stage (T1) esophageal adenocarcinoma: Personalizing the best therapy choice

Kumble LD, Silver E, Oh A, Abrams JA, Sonett JR, Hur C

MINIREVIEWS
418 Mechanisms of action of aqueous extract from the Hunteria umbellata seed and metformin in diabetes

Ejelonu OC

423 Fecal microbiota transplantation: Historical review and current perspective
Leung PC, Cheng KF

META-ANALYSIS
428 Use of music during colonoscopy: An updated meta-analysis of randomized controlled trials

Heath RD, Parsa N, Matteson-Kome ML, Buescher V, Samiullah S, Nguyen DL, Tahan V, Ghouri YA, Puli SR, Bechtold ML

WJMA https://www.wjgnet.com November 28, 2019 Volume 7 Issue 9I

Contents
World Journal of Meta-Analysis

Volume 7 Number 9 November 28, 2019

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DOI: 10.13105/wjma.v7.i9.428 ISSN 2308-3840 (online)

META-ANALYSIS

Use of music during colonoscopy: An updated meta-analysis of
randomized controlled trials

Ryan D Heath, Nasim Parsa, Michelle L Matteson-Kome, Victoria Buescher, Sami Samiullah,
Douglas L Nguyen, Veysel Tahan, Yezaz A Ghouri, Srinivas R Puli, Matthew L Bechtold

ORCID number: Ryan D Heath
(0000-0002-2072-4028); Nasim Parsa
(0000-0003-3882-266X); Michelle L
Matteson-Kome
(0000-0001-8575-1943); Victoria
Buescher (0000-0002-9841-4193);
Sami Samiullah
(0000-0002-1498-0527); Douglas L
Nguyen (0000-0003-3804-0385);
Veysel Tahan (0000-0001-6796-9359);
Yezaz A Ghouri
(0000-0002-8677-1871); Srinivas R
Puli (0000-0001-7650-6938); Matthew
L Bechtold (0000-0002-0205-3400).

Author contributions: Heath RD
and Parsa N contributed equally to
this work; Heath RD, Bechtold ML,
and Parsa N designed research;
Heath RD, Parsa N, Matteson-
Kome ML, Buescher V, and
Bechtold ML performed research;
Matteson-Kome ML, Nguyen DL,
and Puli SR contributed new
reagents/analytic tools; Tahan V,
Ghouri YA, Samiullah S, and
Bechtold ML analyzed data; and
Heath RD, Parsa N, Nguyen DL,
Tahan V, Ghouri YA, Puli SR, and
Bechtold ML wrote the paper.

Conflict-of-interest statement: The
authors deny any conflict of
interest.

Open-Access: This article is an
open-access article which was
selected by an in-house editor and
fully peer-reviewed by external
reviewers. It is distributed in
accordance with the Creative
Commons Attribution Non
Commercial (CC BY-NC 4.0)
license, which permits others to
distribute, remix, adapt, build
upon this work non-commercially,

Ryan D Heath, Nasim Parsa, Michelle L Matteson-Kome, Victoria Buescher, Sami Samiullah,
Veysel Tahan, Yezaz A Ghouri, Matthew L Bechtold, Division of Gastroenterology, University of
Missouri School of Medicine, Columbia, MO 65212, United States

Douglas L Nguyen, Division of Gastroenterology, Heart of the Rockies Regional Medical
Center, Colorado Springs, CO 80907, United States

Srinivas R Puli, Division of Gastroenterology, University of Illinois–Peoria, Peoria, IL 61604,
United States

Corresponding author: Matthew L Bechtold, AGAF, FACG, FACP, FASGE, MD, Professor,
Division of Gastroenterology and Hepatology, Department of Medicine, University Hospital
and Clinics CE405, 5 Hospital Drive, Columbia, MO 65212, United States.
bechtoldm@health.missouri.edu
Telephone: +1-573-8821013
Fax: +1-573-8844595

Abstract
BACKGROUND
Music seems to be beneficial in multiple clinical areas. Colonoscopy is a stressful
event for patients, especially with conscious sedation. Music during colonoscopy
has been evaluated in multiple randomized controlled trials (RCTs) with varied
results. Even meta-analyses on the subject over the years have yielded
inconsistent conclusions. Therefore, we conducted an up-to-date meta-analysis
regarding music during colonoscopy.

AIM
To assess the effects of music played during colonoscopy on patients’
perspectives and sedation requirements.

METHODS
Multiple large databases were aggressively searched (November 2018). RCTs
comparing music to without music during colonoscopy on adult patients were
included. Pooled estimates were calculated for sedative medication doses, total
procedure time, and patients’ experience, willingness to repeat procedure, and
pain scores using odds ratio (OR) and mean difference (MD) with random effects
model.

RESULTS
Eleven studies (n = 988) were included. Music during colonoscopy showed a

WJMA https://www.wjgnet.com November 28, 2019 Volume 7 Issue 9428

and license their derivative works
on different terms, provided the
original work is properly cited and
the use is non-commercial. See:
http://creativecommons.org/licen
ses/by-nc/4.0/

Manuscript source: Unsolicited
manuscript

Received: October 2, 2019
Peer-review started: October 2,
2019
First decision: October 23, 2019
Revised: October 26, 2019
Accepted: November 15, 2019
Article in press: November 15, 2019
Published online: November 28,
2019

P-Reviewer: Cremers I
S-Editor: Zhang L
L-Editor: A
E-Editor: Xing YX

statistically significant reduction in procedure times (MD: -2.3 min; 95%CI: -4.13
to -0.47; P = 0.01) and patients’ pain (MD: -1.26; 95%CI: -2.28 to -0.24; P = 0.02)
while improving patients’ experience (MD: -1.11; 95%CI: -1.7 to -0.53; P < 0.01) as
compared to no music. No statistically significant differences were observed
between music and no music during colonoscopy for midazolam (MD: -0.4 mg;
95%CI: -0.9 to 0.09; P = 0.11), meperidine (MD: -3.06 mg; 95%CI: -10.79 to 4.67; P =
0.44), or patients’ willingness to repeat the colonoscopy (OR: 3.89; 95%CI: 0.76 to
19.97; P = 0.1).

CONCLUSION
Music appears to improve overall patient experience while reducing procedure
times and patient pain. Therefore, music, being a non-invasive intervention,
should be strongly considered during colonoscopy.

Key words: Colonoscopy; Music; Relaxation; Meta-analysis

©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.

Core tip: Music during stressful events has been shown to improve patient experience.
Colonoscopy is a stressful event for many patients. Music during colonoscopy has been
studied by many randomized controlled trials and meta-analyses with varying results.
Therefore, given new studies available for analysis, we performed an updated meta-
analysis. This meta-analysis demonstrated that music during colonoscopy reduces
patients’ pain while improving patients’ experience and procedure times. With these
results and extremely limited adverse effects of music, music should be strongly
considered during colonoscopy.

Citation: Heath RD, Parsa N, Matteson-Kome ML, Buescher V, Samiullah S, Nguyen DL,
Tahan V, Ghouri YA, Puli SR, Bechtold ML. Use of music during colonoscopy: An updated
meta-analysis of randomized controlled trials. World J Meta-Anal 2019; 7(9): 428-435
URL: https://www.wjgnet.com/2308-3840/full/v7/i9/428.htm
DOI: https://dx.doi.org/10.13105/wjma.v7.i9.428

INTRODUCTION
Colonoscopy is an important procedure with screening, diagnostic, and therapeutic
indications, but it is associated with significant patient anxiety. Stress and discomfort
encountered both pre- and intra-operatively are associated with delays in proceeding
with screening colonoscopy, increased medication use during the procedure,
decreased patient satisfaction, and increased patient refusal to repeat colonoscopy[1-3].

Utilization of music during gastrointestinal procedures is a common approach to
reduce patient anxiety, as it has been in many fields of medicine, including radiology,
gynecology, urology, and pulmonology[4-11]. Multiple randomized control trials (RCTs)
have attempted to quantify the effects of music on various aspects of undergoing
colonoscopy. A previous meta-analysis of RCTs demonstrated increased patient
willingness to repeat the procedure when music was utilized in the endoscopy suite;
however, no significant differences in levels of dosage of administered sedative,
patient reported pain level, nor procedure time[12]. Other meta-analyses have also
come to differing conclusions regarding the utility of music during colonoscopy[13-15].
Over time, many other RCTs have been undertaken, demonstrating variable findings
in regards to significant differences in these aforementioned parameters. Some studies
demonstrate reduced anxiety scores and improved satisfaction[16-25]. Some studies
showed reduced pain scores[19,26-27] and reduced sedative requirements[18-19,28-30].
Furthermore, some studies demonstrated little significant difference amongst anxiety
levels nor sedation requirements, though variable improvements in patient experience
and willingness to repeat the procedure[31-35]. Given this variation in results and
sedative medication utilized, this meta-analysis sought to include novel data points
by selecting only studies using moderate sedation to ascertain any significant
differences in patient reported pain, satisfaction, procedure time, sedating medication
requirements, and patient willingness to repeat exam when music is utilized in the
endoscopy suite.

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MATERIALS AND METHODS

Data acquisition
Medline, PubMed, Scopus, Cumulative Index for Nursing and Allied Health
Literature, Cochrane Central Register of Controlled trials, and Embase were searched
for articles (search date November 2018) using “music” and “colonoscopy”. Studies
included were RCTs with adult subjects (age ≥ 18 years) comparing music vs no music
during colonoscopy and only moderate sedation. Two independent reviewers
extracted data using standard forms. Pooled estimates were calculated for the effects
of music for dose of sedative medications (midazolam and meperidine), total
procedure time, and patient’s self-reported pain scores, experience, and willingness to
repeat the same procedure using odds ratio (OR) and mean difference (MD) with
random effects model.

Statistics
The impact of music on patients having colonoscopy was analyzed by calculating
pooled estimates of sedative medication doses (meperidine and midazolam), total
procedure time, and patients’ pain scores, experience, and willingness to repeat the
colonoscopy using OR and MD. A random effects model was utilized to calculate the
summary estimate with significance was indicated by P-value < 0.05. I2 measure of
inconsistency was used to assess heterogeneity.

Quality assessment of studies
The Cochrane’s Collaboration Risk of Bias Tool was used to assess the quality of
included studies[36]. In this tool, each outcome was given a GRADE (very low, low,
moderate, or high) based on the quality of evidence. The parameters evaluated in each
study were as follows: Precision, consistency of results, effect magnitude, and
potential bias (publication and other forms)[37].

RESULTS
The initial search identified 177 articles. Figure 1 of these articles, 11 RCTs (n = 988)
met the inclusion criteria[18,19,25,26,28,29,32,33,35,38,39]. Table 1 all RCTs were published from
2002-2016. Studies were global, including many countries (United States, Germany,
Spain, Japan, Italy, China, Turkey, India, Australia, and Sri Lanka). Most of the
studies were deemed high quality studies based on the Cochrane’s Collaboration Risk
of Bias Tool (Table 2).

Procedure times were evaluated in nine studies[19,25,26,28,29,32,35,38,39]. Music during
colonoscopy demonstrated a statistically significant reduction in procedure times
(MD: -2.3 min; 95%CI: -4.13 to -0.47; P = 0.01). Figure 2 Patient pain scores were
evaluated in six studies[18,19,28,29,33,35]. The use of music during colonoscopy showed
statistically significant decrease in patient pain levels as compared to no music (MD: –
1.26; 95%CI: -2.28 to -0.24; P = 0.02). Figure 3 Furthermore, patient experience was
improved using music as compared to no music (MD: -1.11; 95%CI: -1.7 to -0.53; P <
0.01) in four studies[18,28,29,35]. Figure 4 No statistically significant differences were
observed between music and no music during colonoscopy for midazolam (MD: -0.4
mg; 95%CI: -0.9 to 0.09; P = 0.11), meperidine (MD: -3.06 mg; 95%CI: -10.79 to 4.67; P =
0.44), or patients’ willingness to repeat the procedure (OR: 3.89; 95%CI: 0.76 to 19.97; P
= 0.1).

DISCUSSION
Undergoing colonoscopy is a stressful experience for many patients. The ease of
introducing music into the endoscopy suite makes its use an attractive modality to
enhance the patient experience. Multiple studies demonstrate that use of music not
only subjectively improves patient experience during medical procedures, but
improves objective measures of patient stress including heart rate, blood pressure,
and measured levels of salivary cortisol[16,27,39,40]. As noted above, multiple RCTs have
attempted to demonstrate possible benefits of music during colonoscopy with
variable results. Ten years ago, many authors of this study conducted a meta-analysis
yielding the observation that while music does increase patient willingness to repeat
the procedure, it did not necessarily reduce need for sedating medication, reduce
patient reported pain score, nor reduce procedure time[12]. However, many RCTs
conducted over the ensuing decade supplied new data points which suggest the
benefits of music during colonoscopy may be greater than previously observed, with

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Table 1 Description of studies included in the meta-analysis

Ref. Publication year Number of patients Type of study Type of music

De silva et al[26] 2016 118 RCT Variety per patient

Martindale et al[33] 2013 119 RCT Classical

Costa et al[19] 2010 110 RCT Variety per patient

Bechtold et al[35] 2006 29 RCT Watermark by Enya

Ovayolu et al[18] 2006 32 RCT Turkish classical

Harikumar et al[28] 2006 166 RCT Choice of 6 styles (headphones)

Uedo et al[39] 2004 60 RCT Easy-listening

López-Cepero Andrada et al[25] 2004 78 RCT Classical

Smolen et al[32] 2002 34 RCT Variety per patient

Schiemann et al[38] 2002 133 RCT Variety radio station

Lee et al[29] 2002 109 RCT Variety per patient

RCT: Randomized controlled trial.

possible statistically significant reduced procedure times, patient reported pain scores,
and enhanced overall patient experience.

This meta-analysis concludes that music played during colonoscopy improved
patient experience and procedure times while reducing patient pain. This meta-
analysis is unique from the others given the use of the newest RCTs and minimizing
confounding variables by only using moderate sedation rather than moderate and
deep sedation.

This updated meta-analysis has many strengths. This meta-analysis includes only
RCTs to limit selection and observation bias, more patients than prior meta-analyses,
and global studies. This meta-analysis also focused on only one type of sedation.
However, all meta-analyses have limitations as well. First, music was initiated at
different times during the procedure process, in some studies initiated pre-
procedurally while initiated later in others. Second, the delivery method also differed
amongst studies, with some patients receiving music via headphones and others via a
radio in the room. Third, the genre of music varied widely amongst these studies with
some studies utilized classical or easy listening selections, while other studies allowed
patients to select their own music. The inevitable variation of any given individual
patient’s response to different music selections, particularly when considering
cultural and generational preferences as well as response to stressful stimuli, must be
considered when translating these results into one’s own clinical practice. Naturally,
music selection likely also alters the behavior of the performing endoscopist with new
evidence that selection of music can affect adenoma detection rate[41].

In conclusion, given the low cost and relative ease of introducing music during
colonoscopy, these results suggest it is reasonable to include music to both improve
patient pain and experience as well as possibly productivity given reduced procedure
times.

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Table 2 Quality assessment summary of all included studies

Ref.
Study
design

Random
sequence
generation

Allocation
con-
cealment

Blinding
Blinding
outcome
assessment

Incomplete
outcome
data

Selective
reporting

Other bias
Quality
assessment

De silva et
al[26], 2016

RCT Adequate Adequate Double-
blinded

Adequate None None None High

Martindale
et al[33], 2013

RCT Adequate Adequate Double-
blinded

Adequate None None None High

Costa et
al[19], 2010

RCT Adequate Inadequate Single-
blinded

Adequate None None None Moderate

Bechtold et
al[35], 2006

RCT Adequate Not described None Inadequate None None None Low

Ovayolu et
al[18], 2006

RCT Adequate Adequate Double-
blinded

Adequate None None None High

Harikumar
et al[28], 2006

RCT Adequate Adequate Single-
blinded

Adequate None None None Moderate

Uedo et al[39],
2004

RCT Not described Not described Double-
blinded

Adequate None None None Low

López-
Cepero
Andrada et
al[25], 2004

RCT Not described Adequate Double-
blinded

Adequate None None None Moderate

Smolen et
al[32], 2002

RCT Not described Adequate Double-
blinded

Adequate None None None Moderate

Schiemann
et al[38], 2002

RCT Not described Adequate Double-
blinded

Adequate None None None Moderate

Lee et al[29],
2002

RCT Not described Adequate Double-
blinded

Adequate None None None Moderate

RCT: Randomized controlled trial.

Figure 1

Figure 1 Details of search algorithm.

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Figure 2

Figure 2 Forest plot showing comparison between music and no music during colonoscopy for procedure time.

Figure 3

Figure 3 Forest plot showing comparison between music and no music during colonoscopy for patients’ pain.

Figure 4

Figure 4 Forest plot showing comparison between music and no music during colonoscopy for patients’ experience.

ARTICLE HIGHLIGHTS
Research background
Music during colonoscopy has been a controversy subject despite multiple randomized
controlled trials and meta-analyses. Studies vary from music during colonoscopy helping reduce
need for sedative medications and enhancing patient experience to offering little to no benefit.
Given this variability, we conducted this meta-analysis to include all studies to-date and limiting
them to only conscious sedation.

Research motivation
To determine if music is beneficial to patients undergoing colonoscopy. If beneficial, music
would be a very low-cost intervention to improve patients’ experience and pain during a very
stressful procedure.

Research objectives
The objectives of this research were to fully assess the effects of music during colonoscopy
sedative medication doses (meperidine and midazolam), total procedure time, and patients’ pain
scores, experience, and willingness to repeat the colonoscopy.

Research methods

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A meta-analysis was performed by calculating pooled estimates of sedative medication doses
(meperidine and midazolam), total procedure time, and patients’ pain scores, experience, and
willingness to repeat the colonoscopy using odds ratio and mean difference using a random
effects model.

Research results
This research showed that music during colonoscopy improved patient experience and
procedure times while reducing patient pain.

Research conclusions
Music is a benefit to patients undergoing the stressful procedure of colonoscopy. Music during
colonoscopy improves the patient experience while reducing pain. In addition, procedure times
are improved with music playing during colonoscopy. Music is a low-cost intervention that
shows significant benefit and should strongly be considered in endoscopy suites. In the future,
more endoscopy suites should be equipped with music.

Research perspectives
This meta-analysis shows that music has a role in the endoscopy suite. Also, this meta-analysis
demonstrates that with more studies, the results of any meta-analysis may be significantly
altered as these results differ from some prior meta-analyses.

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2 Shafer LA, Walker JR, Waldman C, Yang C, Michaud V, Bernstein CN, Hathout L, Park J, Sisler J,
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3 Wangmar J, von Vogelsang AC, Hultcrantz R, Fritzell K, Wengström Y, Jervaeus A. Are anxiety levels
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10.1136/bmjopen-2018-025109]

4 Dubois JM, Bartter T, Pratter MR. Music improves patient comfort level during outpatient bronchoscopy.
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5 Colt HG, Powers A, Shanks TG. Effect of music on state anxiety scores in patients undergoing fiberoptic
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6 Triller N, Erzen D, Duh S, Petrinec Primozic M, Kosnik M. Music during bronchoscopic examination: the
physiological effects. A randomized trial. Respiration 2006; 73: 95-99 [PMID: 16293960 DOI:
10.1159/000089818]

7 Chan YM, Lee PW, Ng TY, Ngan HY, Wong LC. The use of music to reduce anxiety for patients
undergoing colposcopy: a randomized trial. Gynecol Oncol 2003; 91: 213-217 [PMID: 14529684 DOI:
10.1016/s0090-8258(03)00412-8]

8 Danhauer SC, Marler B, Rutherford CA, Lovato JF, Asbury DY, McQuellon RP, Miller BE. Music or
guided imagery for women undergoing colposcopy: a randomized controlled study of effects on anxiety,
perceived pain, and patient satisfaction. J Low Genit Tract Dis 2007; 11: 39-45 [PMID: 17194950 DOI:
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9 Yeo JK, Cho DY, Oh MM, Park SS, Park MG. Listening to music during cystoscopy decreases anxiety,
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[PMID: 23009573 DOI: 10.1089/end.2012.0222]

10 Slifer KJ, Penn-Jones K, Cataldo MF, Conner RT, Zerhouni EA. Music enhances patients’ comfort during
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11 Nagata K, Iida N, Kanazawa H, Fujiwara M, Mogi T, Mitsushima T, Lefor AT, Sugimoto H. Effect of
listening to music and essential oil inhalation on patients undergoing screening CT colonography: a
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12 Bechtold ML, Puli SR, Othman MO, Bartalos CR, Marshall JB, Roy PK. Effect of music on patients
undergoing colonoscopy: a meta-analysis of randomized controlled trials. Dig Dis Sci 2009; 54: 19-24
[PMID: 18483858 DOI: 10.1007/s10620-008-0312-0]

13 Rudin D, Kiss A, Wetz RV, Sottile VM. Music in the endoscopy suite: a meta-analysis of randomized
controlled studies. Endoscopy 2007; 39: 507-510 [PMID: 17554644 DOI: 10.1055/s-2007-966362]

14 Tam WW, Wong EL, Twinn SF. Effect of music on procedure time and sedation during colonoscopy: a
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15 Shanmuganandan AP, Siddiqui MRS, Farkas N, Sran K, Thomas R, Mohamed S, Swift RI, Abulafi AM.
Does music reduce anxiety and discomfort during flexible sigmoidoscopy? A systematic review and meta-
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16 Palakanis KC, DeNobile JW, Sweeney WB, Blankenship CL. Effect of music therapy on state anxiety in
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17 Hayes A, Buffum M, Lanier E, Rodahl E, Sasso C. A music intervention to reduce anxiety prior to
gastrointestinal procedures. Gastroenterol Nurs 2003; 26: 145-149 [PMID: 12920428]

18 Ovayolu N, Ucan O, Pehlivan S, Pehlivan Y, Buyukhatipoglu H, Savas MC, Gulsen MT. Listening to
Turkish classical music decreases patients’ anxiety, pain, dissatisfaction and the dose of sedative and
analgesic drugs during colonoscopy: a prospective randomized controlled trial. World J Gastroenterol
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need help revising my evidence based guidelines article review

APPENDIX A

Appraisal Guide:

Recommendations of a Clinical Practice Guideline

Citation:

_________________________________________________________________________

_________________________________________________________________________

_________________________________________________________________________

Synopsis

What group or groups produced the guideline?

What does the guideline address? Clinical questions, conditions, interventions?

What population of patients does the guideline address?

Did the panel use existing SRs or did it conduct its own?

What clinical outcomes was the guideline designed to achieve?

What are the main recommendations?

What system was used to grade the recommendations?

Credibility

Was the panel made up of people with the necessary expertise?  Yes   No   Not clear

Are the goals for developing the guideline explicit and clear?  Yes   No   Not clear

*Does the guideline production process include all the widely

recognized steps?  Yes   No   Not clear

*Were the SRs used of high quality?  Yes   No   Not clear

Are differences in evidence for subpopulations recognized?  Yes   No   Not clear

*Is the evidence supporting each

recommendation graded or stated as adequate to strong?  Yes   No   Not clear

Is the guideline current? (based on

issue date and date of most recent evidence included)  Yes   No   Not clear

Are the recommendations credible?  Yes All   Yes Some   No

Clinical Significance

Are essential elements of any
recommended action or intervention clearly stated?  Yes   No   Not clear

*Is the magnitude of benefit associated
with each recommendation clinically important?  Yes   No   Not clear

*Is the panel’s certainty or confidence
in each recommendation clear?  Yes   No   Not clear

Were patient concerns, values, and risks addressed?  Yes   No   Not clear

Were downsides or costs of each recommendation addressed?  Yes   No   Not clear

Was the guideline reviewed by
outside experts and a member of
the public or field tested?  Yes   No   Not clear

Are the recommendations
clinically significant?  Yes All   Yes Some   No

Applicability

Does the guideline address a problem,
weakness, or decision we are examining in our setting?  Yes   No

Did the research evidence involve
patients similar to ours, and was the
setting similar to ours?  Yes   No   Some

What changes, additions, training, or
purchases would be needed to
implement and sustain a clinical
protocol based on these conclusions? Specify.

____________________________________________________________________________

____________________________________________________________________________

*Is what we will have to do to implement the new protocol realistically achievable by us (resources, capability, commitment)?  Yes   No   Not clear

Which departments and/or providers will be affected by a change? Specify.

____________________________________________________________________________

____________________________________________________________________________

*How will we know if our patients are benefiting from our new protocol? Specify.

____________________________________________________________________________

____________________________________________________________________________

Are the recommendations
applicable to our situation?  Yes All   Yes Some   No

Should we proceed
to design a protocol
based on these recommendations?  Implement All   Implement Some   No

* = Important criteria

Comments

____________________________________________________________________________

____________________________________________________________________________

APP A-2 Brown

Brown APP A-1

need help revising my evidence based guidelines article review

Critique each article using the appropriate appraisal form.

·
Clinical Practice Guideline

 Download Clinical Practice Guideline

Use the information below to help you know which section of the article to use to answer the questions in the template:

· Introduction and its subsections have the purpose or WHY study done.>

· Methodssection and its subsections contains HOW the study was done.

· Results, Discussion and Conclusionssection have WHAT was found.

need help revising my evidence based guidelines article review

APPENDIX A

Appraisal Guide:

Recommendations of a Clinical Practice Guideline

Citation:

_________________________________________________________________________

_________________________________________________________________________

_________________________________________________________________________

Synopsis

What group or groups produced the guideline?

What does the guideline address? Clinical questions, conditions, interventions?

What population of patients does the guideline address?

Did the panel use existing SRs or did it conduct its own?

What clinical outcomes was the guideline designed to achieve?

What are the main recommendations?

What system was used to grade the recommendations?

Credibility

Was the panel made up of people with the necessary expertise?  Yes   No   Not clear

Are the goals for developing the guideline explicit and clear?  Yes   No   Not clear

*Does the guideline production process include all the widely

recognized steps?  Yes   No   Not clear

*Were the SRs used of high quality?  Yes   No   Not clear

Are differences in evidence for subpopulations recognized?  Yes   No   Not clear

*Is the evidence supporting each

recommendation graded or stated as adequate to strong?  Yes   No   Not clear

Is the guideline current? (based on

issue date and date of most recent evidence included)  Yes   No   Not clear

Are the recommendations credible?  Yes All   Yes Some   No

Clinical Significance

Are essential elements of any
recommended action or intervention clearly stated?  Yes   No   Not clear

*Is the magnitude of benefit associated
with each recommendation clinically important?  Yes   No   Not clear

*Is the panel’s certainty or confidence
in each recommendation clear?  Yes   No   Not clear

Were patient concerns, values, and risks addressed?  Yes   No   Not clear

Were downsides or costs of each recommendation addressed?  Yes   No   Not clear

Was the guideline reviewed by
outside experts and a member of
the public or field tested?  Yes   No   Not clear

Are the recommendations
clinically significant?  Yes All   Yes Some   No

Applicability

Does the guideline address a problem,
weakness, or decision we are examining in our setting?  Yes   No

Did the research evidence involve
patients similar to ours, and was the
setting similar to ours?  Yes   No   Some

What changes, additions, training, or
purchases would be needed to
implement and sustain a clinical
protocol based on these conclusions? Specify.

____________________________________________________________________________

____________________________________________________________________________

*Is what we will have to do to implement the new protocol realistically achievable by us (resources, capability, commitment)?  Yes   No   Not clear

Which departments and/or providers will be affected by a change? Specify.

____________________________________________________________________________

____________________________________________________________________________

*How will we know if our patients are benefiting from our new protocol? Specify.

____________________________________________________________________________

____________________________________________________________________________

Are the recommendations
applicable to our situation?  Yes All   Yes Some   No

Should we proceed
to design a protocol
based on these recommendations?  Implement All   Implement Some   No

* = Important criteria

Comments

____________________________________________________________________________

____________________________________________________________________________

APP A-2 Brown

Brown APP A-1

need help revising my evidence based guidelines article review

Critique each article using the appropriate appraisal form.

·
Clinical Practice Guideline

 Download Clinical Practice Guideline

Use the information below to help you know which section of the article to use to answer the questions in the template:

· Introduction and its subsections have the purpose or WHY study done.>

· Methodssection and its subsections contains HOW the study was done.

· Results, Discussion and Conclusionssection have WHAT was found.

need help revising my evidence based guidelines article review

Vocal Music Therapy for Chronic Pain:
A Mixed Methods Feasibility Study

Ming Yuan Low, MA, MT-BC,1 Clarissa Lacson, MA, MT-BC,1 Fengqing Zhang, PhD,2

Amy Kesslick, MA, MT-BC, LPC,3 and Joke Bradt, PhD, MT-BC1

Abstract

Objective: The purpose of this study was to determine the feasibility and preliminary effects of a vocal music
therapy (VMT) program on chronic pain management.

Design: A mixed methods intervention design was used in which qualitative data were embedded within a
randomized controlled trial.

Setting: An urban nurse-management health center on the East Coast of the United States.
Subjects: Participants (N = 43) were predominantly Black (79%) and female (76.7%) with an average pain

duration of 10 years.
Intervention: Participants were randomly allocated to a 12-week VMT program or a waitlist control.
Outcome measures: We tracked consent rate (percentage of participants enrolled out of total number

screened), attrition rate, and treatment adherence. We used PROMIS

(Patient Reported Outcomes Measure-
ment Information System) tools to measure pain interference, pain-related self-efficacy, pain intensity, de-
pression, anxiety, positive effect, and well-being, ability to participate in social activities, and satisfaction with
social roles at baseline and week 12. VMT participants also completed the Patient Global Impression of Change
Scale. We conducted semistructured interviews to better understand participants’ experience of the intervention.

Results: The consent rate was 56%. The attrition rate was 23%. Large treatment effects (partial eta squared) were
obtained for self-efficacy (0.20), depression (0.26), and ability to participate in social activities (0.24). Medium effects
were found for pain intensity (0.10), anxiety (0.06), positive effect, and well-being (0.06), and small effects for pain
interference (0.03) and satisfaction with social roles (0.03). On average, participants felt moderately better after
completion of the VMT program (M = 4.93, standard deviation = 1.98). Qualitative findings suggest that VMT resulted
in better self-management of pain, enhanced psychological well-being, and stronger social and spiritual connections.

Conclusions: Recruitment into the 12-week program was challenging, but quantitative and qualitative
findings suggest significant benefits of VMT for chronic pain management.

Keywords: music therapy, pain management, clinical trials

Introduction

Chronic pain is a significant public health problemamounting to an annual health care expense of ap-
proximately half a trillion dollars in the United States

alone.
1

In 2016, the Centers for Disease Control and
Prevention issued recommendations to move away from
opioids and instead use nonpharmacological thera-
pies for the treatment of chronic pain.

2
The use of music

for the management of chronic pain is increasingly

Departments of 1Creative Arts Therapies and 2Psychology, Drexel University, Philadelphia, PA.
3Stephen and Sandra Sheller 11th Street Family Health Services, Drexel University, Philadelphia, PA.

ª Ming Yuan Low, et al. 2019; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms
of the Creative Commons Attribution Noncommercial License (http://creativecommons.org/licenses/by-nc/4.0/) which
permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the
source are cited.

THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE

JACMVolume 26, Number 2, 2020, pp. 113–122Mary Ann Liebert, Inc.
DOI: 10.1089/acm.2019.0249

113

gaining interest, but more efficacy research is needed to
encourage health care providers to recommend its use to
patients.

3,4

To date, research on the use of music for pain has focused
primarily on listening to prerecorded music for acute pain
management with reported treatment benefits for reducing
pain intensity and opioid requirements.

5,6
A recent review

3

on the impact of music on chronic pain reported a moderate
effect size for pain (standardized mean difference = 0.60),
but results were inconsistent across studies (I

2 = 60%). The
majority of the studies (11/14) in this review employed
listening to prerecorded music; one study used choir singing,
and two studies used listening to live music.

The pain-reducing effects of music are often attributed to
music’s ability to distract and relax. However, chronic pain
is a complex phenomenon that affects individuals physi-
cally, mentally, socially, and spiritually and its management,
therefore, requires interventions that go beyond cognitive
distraction.

7
Therefore, we developed a vocal music therapy

(VMT) treatment program that addresses biopsychosocial
components of chronic pain management.

8

Music therapy is the clinical use of music interventions to
help clients optimize their health within a therapeutic rela-
tionship with a board-certified music therapist.

9,10
The VMT

group sessions use toning (i.e., singing of elongated vowels)
and humming, music-guided breathing, group singing, vocal
improvisations, verbal processing of emotions and thoughts
evoked by the music experiences, as well as psychoeduca-
tion about how music can address biopsychosocial factors
that impact chronic pain management. We briefly summa-
rize here the intervention’s theoretical framework, but
readers are referred to Bradt et al.

8
for a more in-depth

discussion.
On a bioneurological level, music listening and music

making activate brain areas involved with reward, emo-
tion, and arousal such as the nucleus accumbens, amygdala,
anterior insula, cingulate cortex, orbitofrontal cortex, and
mediodorsal thalamus, through which affective and cogni-
tive modulation of pain can be achieved.

11–13
On a psycho-

logical level, toning and humming are used to help enhance
body awareness, promote a positive connection with one’s
body, and facilitate relaxation. Since people with chronic
pain often try to disconnect from their body to ‘‘escape’’
the pain, these are considered important mechanisms in
chronic pain management.

14

Singing and active music making also help facilitate
emotional expression; emotional expressivity has been
shown to improve a sense of well-being and self-reliance in
people with chronic pain.

15
Finally, group music making

facilitates social inclusion and a sense of belonging.
16,17

Because people with chronic pain often feel isolated, this is
an important aspect of the VMT group.

The VMT program was initially tested as an 8-week
program.

8
Study findings were promising with large and

moderate effect sizes for pain-related self-efficacy and
pain interference, respectively, but participants unanimously
agreed that a longer program was desirable. Yet, concerns
were raised by health care providers at the study site about
the feasibility to recruit people with chronic pain to a
lengthier program. Therefore, the purpose of this mixed
methods feasibility study was to (1) determine the feasibility
of a 12-week VMT protocol; (2) provide estimates of effect

for core outcomes in chronic pain management; and (3)
obtain qualitative data about participant experiences of the
VMT program.

Materials and Methods

Study design

We employed a mixed methods intervention design,
18

in
which qualitative data (i.e., semistructured interviews) were
embedded within a randomized controlled trial. Participants
were randomized to the VMT or waitlist control (WLC)
treatment arm using a computer-generated list of random
numbers. Allocation concealment was achieved through the
use of sequentially numbered, opaque, sealed envelopes.
Since self-report measures were used for all outcomes, out-
come assessment could not be blinded as participants were
aware of their treatment allocation. However, the statistician
was blinded to group assignments (Fig. 1).

Participants

Participants were recruited from an urban nurse-managed
health center that predominantly serves inner-city, low-
income African Americans. Eligibility criteria are included
in Table 1. Participant demographic and clinical character-
istics at baseline are presented in Table 2. The majority of
the participants were female (76.7%), were black (79%),
were on disability leave (60.5%), and had an average pain
duration of 10 years. No significant between-group differ-
ences were present at baseline. The study was approved by
an Institutional Review Board. Informed consent was ob-
tained from all participants. We recruited participants in
three waves. In each wave, participants were randomly as-
signed to VMT or WLC. WLC participants were invited to
participate in the VMT intervention after completion of the
outcome measures at the end of the waitlist period.

Interventions

Vocal music therapy. Participants in the VMT treatment
program received twelve 90-min weekly group therapy
sessions (four to six participants). Sessions were led by a
board-certified music therapist. The VMT sessions followed
a similar structure, but were each focused on a different
topic related to music-based pain management (Table 3).

After a brief music-guided deep breathing exercise and
verbal check-in, the music therapist led the participants into
toning (i.e., singing elongated vowels) and humming expe-
riences. Using the voice in this manner can help facilitate
greater body awareness and promote relaxation. The group
then talked about somatic sensations experienced during the
breathing and toning exercises.

The session then moved into vocal music improvisations.
Percussion instruments were often added, resulting in en-
ergetic music making. These improvisations provided op-
portunities for emotional expression. Furthermore, group
music making enabled participants to relate to others and
share some of their struggles in novel ways. Verbal pro-
cessing after the improvisation often evolved into additional
improvisations focused on the main ideas of the group
discussion.

Throughout the sessions, psychoeducation was pro-
vided about how music can address biological (e.g., music

114 LOW ET AL.

stimulates dopaminergic activity resulting in improved
mood), psychological (e.g., song lyrics can help validate
one’s feelings), and social (e.g., group music making creates
a sense of belonging) factors that play an important role in
chronic pain management. Education about why and how
music can address pain management can help with trans-
ferability of skills and knowledge outside of the session
room and equips participants to explain to family and
friends how music-based self-management techniques help
them with their pain.

Each session ended with singing a song listed by one of
the group members during intake. Participants were asked to
underline a lyric that was particularly meaningful to them
and could possibly be a source of emotional support during
the week. The therapist then facilitated a discussion about
the meaning of the selected lyrics.

8
The music therapist was

trained by J.B. using a treatment manual. Each session was
recorded and reviewed by J.B. to ensure treatment fidelity.

The original protocol tested in a previous study consisted
of eight 60-min sessions. The 12-week protocol was very
similar to the 8-week protocol, except that (1) the longer

session length allowed for more time for each music expe-
rience and group processing and (2) the longer program
length allowed for review sessions to revisit insights and
music-based pain management skills gained. The VMT
treatment manual will be published in the near future.

Waitlist control. Participants in the WLC group received
care as usual at the health center. At the center, chronic pain
management typically consists of pharmacological treat-
ment and physical therapy services. Additional comple-
mentary services are available, including yoga and fitness
classes.

Outcome measures

To determine feasibility, we tracked the following: (1)
consent rate (percentage of participants enrolled out of total
number screened); (2) attrition rate; and (3) treatment com-
pliance (number of sessions attended). To measure the ef-
fects of the intervention, we used the Patient Reported
Outcomes Measurement Information System (PROMIS


)
19

short forms (SF) to measure pain interference (SF-6b),
pain-related self-efficacy (SF-6), pain intensity (SF-3a),
depression (SF-4a), anxiety (SF-4a), positive effect, and
well-being (SF), ability to participate in social activities (SF-
4a), and satisfaction with social roles and activities (SF-4a).
Finally, participants rated their perception of improvement
using the Patient Global Impression of Change Scale (PGIC).

20

Measurements were administered at baseline and week 12.
After completion of the week 12 measurements, participants
(including WLC participants who opted to receive VMT after
the WLC period) were invited to participate in a semi-
structured interview aimed at better understanding their ex-
perience of the intervention (Appendix 1). Measurements and
interviews were administered by research assistants.

FIG. 1. Participant flow chart.

Table 1. Study Eligibility Criteria

Inclusion criteria Exclusion criteria

English-speaking
adults

Moderate to profound auditory
deficits

Age 18 or older Severe progressive medical or
neurological comorbidities

Chronic pain
for ‡3 months

Severe psychiatric disorder

Pain impact score
of ‡27 (moderate
impact)

a

Cognitive impairment
Current alcohol or drug problem
Currently receiving music therapy

services

a
Impact score items derived from Deyo et al.

35

VOCAL MUSIC THERAPY FOR CHRONIC PAIN 115

Data analysis

Quantitative data. For each of the outcome variables, we
compared the average difference between the VMT and WLC
conditions in improvements of the outcome from baseline to
week 12. T-scores were used for all PROMIS tools.

21
Raw

scores were used for the PGIC. Due to the small sample size,
mean difference of improvement from baseline to week 12
between the two conditions and the 95% confidence interval
(CI) was reported and used for inference. In addition, we
compared the improvement in the outcomes between the two
conditions controlling for baseline values. Partial eta squared
from ANCOVA was used to quantify the effect size and

was interpreted as small (0.01), moderate (0.06), and large
(0.14).

22,23
Given the limited sample size, we based our in-

ference on effect sizes.
24,25

Qualitative data. The transcripts of the interviews were
imported into MAXQDA 11

26
and analyzed by two coders

( M.Y.L. and C.L.) to ensure scientific rigor. We used the-
oretical thematic analysis procedures as outlined by Braun
and Clarke.

27
Coding was based on a semantic approach in

which codes are derived from ‘‘the explicit meaning of the
data and the analyst is not looking for anything beyond what
a participant has said’’

27
(p. 84). After codes were agreed

upon by both coders, they were organized into categories.
These were presented to J.B. for input and were compared
against the text excerpts associated with the codes for ver-
ification. The categories were then organized into broader
themes. After final categories and themes were agreed upon,
definitions for the categories and themes were developed.

Results

Feasibility

The consent rate was 56%. Of the 43 participants who
completed the baseline, 33 completed the postintervention
measures. This represents an attrition rate of 23% (Fig. 1).
Of the VMT participants, nine participants attended nine or
more sessions. Failure to attend a session was mainly due to
childcare issues, family emergencies, bad weather, health
issues, and traveling.

Preliminary efficacy

Table 3 details the mean change scores (baseline to week
12) and standard deviations (SDs) for each group as well as

Table 2. Sociodemographic and Clinical Characteristics of Study Participants at Baseline

Characteristic Music therapy (n = 22) Waitlist control (n = 21) p

Age, years, mean (SD) 48.76 (9.95) 51.38 (16.87) 0.12
Gender, female, n (%) 16 (72.73) 17 (80.95) 0.45
Race, n (%) 0.20

Black 18 (81.82) 16 (76.19)
Caucasian 3 (13.64) 0 (0)
Asian 1 (4.5) 0 (0)
American Indian or Alaska Native 0 (0) 1 (4.8)
Multiracial 0 (0) 4 (19.05)

Employment, n (%) 1.0
Employed 3 (13.63) 2 (9.52)
Unemployed 4 (18.18) 3 (14.29)
Retired 1 (4.5) 2 (9.52)
On disability 13 (59.1) 13 (61.9)

Duration of pain, years, mean (SD) 9.43 (7.02) 10.43 (11.13) 0.68
Pain diagnosis,

a
n (%) 0.71

Arthritis 8 (36.36) 10 (47.62)
Degenerative disc/spinal stenosis 2 (9.09) 3 (14.29)
Neuropathy 3 (13.63) 1 (4.76)
Fibromyalgia 2 (9.09) 2 (9.52)

Pain impact score 37.40 (6.64) 39.19 (6.39) 0.36
Prior music performance experience,

b
n (%) 0.75

Yes 13 (59.1) 11 (52.38)
No 8 (38.10) 10 (47.62)

a
Most commonly reported pain diagnoses.

b
Having played an instrument or sung in a choir.

SD, standard deviation.

Table 3. Session Topics

Session
number Session topic

1 Introduction and rapport building
2 Music making to enhance body awareness
3 Music-based techniques to promote self-care

and acceptance
4 Music-based self-management of pain and stress
5 Music as motivator for physical activity
6 Review session: Review skills learned/insights

gained to date
7 Music as a source of strength and inspiration
8 Emotional expressivity through music
9 Enhancing social support through music

10 Music as source of empowerment
11 Develop plan for maintenance of music-based

skills
12 Closure session

116 LOW ET AL.

the effect sizes. There was a large treatment effect of VMT
for pain-related self-efficacy, depression, and ability to par-
ticipate in social activities. The 95% CIs associated with
these large effect sizes suggest that these findings were sta-
tistically significant. Medium treatment effects were found
for pain intensity, anxiety, and positive affect and well-
being, and small effect sizes for pain interference and sat-
isfaction with social roles. The 95% CIs of these medium
and small effect sizes suggest that these were not statisti-
cally significant. On average, PGIC scores (M = 4.93, SD =
1.98) suggest that participants felt moderately better after
completion of the VMT program (Table 4).

Qualitative results

A total of 25 participants took part in the semistructured
interviews. All participants reported that the VMT sessions
were beneficial in helping them manage their pain inside
and outside of sessions (Theme 1, Pain Management). One
participant remarked, ‘‘Every time I play the instruments, it
helped me with my pain [.] That drum playing changed
my pain in some kinda way. ‘Cuz I didn’t have it [pain] once
I stopped doing the drums.’’ Participants shared that they
used VMT strategies to assist them with their daily activities
and chores or for motivation in the morning: ‘‘I wasn’t
feeling too good this morning. I turned on some music and it
took my mind off of that feeling. I was able to get dressed on
time and I made it here on time.’’

Some participants reported using music-based skills as al-
ternatives to their pain medication as the music helped to soothe
the pain and refocus their attention. Other participants stated
that the music made their pain ‘‘go away’’: ‘‘That day I was
having a lot of pain. We started singing and [.] it just went
away.’’ One person commented how purposefully music lis-
tening helped them with daily activities: ‘‘There are certain
songs I like, I can get into the rhythm of them. I just focus on the
music part, and it gave me a rhythm. As long as I was listening
to the music when I was working, I was able to keep going.’’

Many participants reported enhanced psychological well-
being in response to the VMT experiences and the psy-
choeducation about how music can address different factors
that influence their pain (Theme 2, Improved Psychological
Well-being). Participants shared that the VMT program led

to (1) better understanding of the contribution of stress and
other emotions to their pain, (2) greater awareness of the
presence of stress and uncomfortable emotions, and (3)
learning new music-based skills to help deal with mental
states that exacerbated their pain. One participant shared the
following: ‘‘I have step-children that I take care of. It can
become overwhelming. [Music] helps me just take that
moment to woosh (sic) and [.] release that negativity so
they don’t see that and feel that.’’

Some participants told us that they are now more inten-
tional with their use of music and that they create playlists
for specific purposes. Participants also emphasized that
learning to be kinder to oneself, achieving mindfulness, and
understanding who they are were important skills gained from
the program. One person shared that ‘‘keeps you away from
that self-blame—because that [self-blame] adds to the pain.’’
A large number of comments referred to feeling empowered to
prioritize one’s mental health and physical needs over de-
mands by others and seeking out things in life that bring joy.
Participants also appreciated that attending the program was a
form of self-care as expressed by one participant: ‘‘It made me
feel like I’m doing something for myself.’’

The third and final theme (Developing Meaningful Con-
nections) relates to music aiding in facilitating deeper
connections with one’s spirituality and stronger bonds with
others. One participant commented, ‘‘The spiritual aspect of
music and the emotional feelings that I got from just beating on
the drum, or playing the tambourine, or that ocean drum!’’

Many participants reminisced fondly about the bonds
among the group members that were created through the
VMT program. One participant said, ‘‘It was wonderful
because the group started out with everybody was in their
little shell. [.] And on the recording [excerpts from ses-
sions] that we heard after the group, we just heard our story,
and like how amazing how everybody developed. And we
became united. We became a family.’’ Another participant
appreciated the accepting and nonjudgmental environment
the group provided, ‘‘With friends or family or romantic
partners or even doctors, sometimes struggling so much to
explain intermittent, invisible chronic pain to the point of
disability [.] Hearing and being understood and sharing
just felt really comfortable and in a way that I had not ex-
perienced.’’ Participants shared that these bonds continued
outside of the sessions (Table 5).

Table 4. Change in T-Scores, Mean Difference and Effect Size

Outcome

Change score (SD)
a

MD (95% CI)
b

Effect size (Zp
2
)VMT WLC

Pain-related self-efficacy 4.84 (5.14) -0.26 (4.76) 5.10 (1.52 to 8.68) 0.20
Pain interference -2.46 (5.06) -0.45 (3.52) -2.01 (-5.17 to 1.15) 0.03
Pain intensity -5.7 (7.24) -1.86 (4.47) -3.85 (-8.19 to 0.49) 0.10
Anxiety -2.42 (8.55) 0.39 (7.32) -2.82 (-8.56 to 2.94) 0.06
Depression -4.92 (4.83) 2.56 (7.99) -7.48 (-12.25 to -2.71) 0.26
Positive affect and well-being 0.14 (6.8) -2.22 (5.96) 2.36 (-2.27 to 6.98) 0.06
Ability to participate in social activities 2.26 (3.62) -2.55 (6.53) 4.81 (0.99 to 8.62) 0.24
Satisfaction with social roles 1.59 (5.82) -0.51 (6.86) 2.10 (-2.49 to 6.70) 0.03

a
change from baseline to week 12.

b
Ninety-five percent CI intervals that do not include the value zero suggest that the findings are statistically significant.
Zp

2
, partial eta squared based on ANCOVA.

CI, confidence interval; MD, mean difference; SD, standard deviation; VMT, vocal music therapy; WLC, waitlist control.

VOCAL MUSIC THERAPY FOR CHRONIC PAIN 117

Table 5. Qualitative Findings

Themes and definitions Categories and definitions Example quotes

Theme 1 Pain
management:
The VMT program
offers participants
strategies to manage
pain in their daily lives.

Enhanced physical
functioning:
Music engagement helps
to improve activity
levels and ability to do
chores

But I use the soft jazz just to help with. I just sit there and
listen to it and I close my eyes. And I just rub my knees
[.] and when I feel like the feeling is going to be okay
and I can get up and not have a limp or anything, I get
up. And then, I don’t have no limp. The knee don’t be
bothering me.

I use to could not even walk 2 or 3 blocks. I would have to
like really sit down and take a breather. But it just seemed
like once I came here [.] and we just got into the
mood.once everything was over, I’d go home and I’m
like ‘‘I’m not in no pain at all.’’ And I never realize it and
I’m like doing all this stuff (chores) in the house.

Reducing pain:
Music brings pain relief
through its soothing
qualities as well as
through refocusing of
attention

I would describe it [the music] as a de-stressor. A way to
rethink, recharge your mind in a different direction and
also to take your mind off the pain.I’m not going to say
it can totally go away but it’ll subside a little to a point
where you’re functional.

I liked the ocean drum. That is really soothing, and it just
relaxed my whole body. I just listened to the sound of it, and
it takes you to sitting on the beach (in your imagination) and
just watching the waves. It was really peaceful.

When the pain begins to come, I try to hum [.] just direct
my attention to something else.

Theme 2 Improved
psychological well-
being:
VMT strategies help
manage difficult
psychological and
emotional states that
contribute to pain.

Achieving mindfulness:
Music helps participants
be more present by
creating a relaxed and
clearer state of mind.

A lot of the music that we’ve used were meditative, so it
kind of allows me to broaden like, my mind and my
perception.with sounds.

I do music for de-stress. And to take my mind off the
pain.it’s like a rethinking process. mindfulness. So
when I’m mindful, first I do mindful exercises and
breathing. Recognizing my own breath. My own
heartbeat. And it tends to calm down.

Empowerment:
VMT empowers
participants to prioritize
self-care, helps to
restore hope, and
motivates to be active.

And there’s this sign of hope. That’s what I liked about the
songs.that they’re sign of hope, they’re sign of
welcoming.

It helps your day to keep going. [.] you look over at the
other person, and you see that their struggles might be a
little different than yours. But you see how they push
through it. So to me, it makes me push through it even
more because I’m like, ‘‘Okay, you know.I’m gonna
keep going.’’

Also, just learning patience with my pain and being kinder
to my body about it. In the sense of, you know, I feel like
for a long time it was mostly just being mad and having
that energy toward whatever part of my body was not
feeling good or what I couldn’t do, so I think a lot of what
I took from that was, you know, focusing on what I can do
now, what I can do to help myself, and something like
that. Yeah. I do have, I have a lot more now.

You were allowed to sing lousy or you were allowed to be
off key. [.] In the group it just didn’t matter. I watched
people’s volume—as their confidence level went up, their
volume increased. Their voices were being heard.

The songs that we would sing, it really was so motivating.
I felt like I was somewhere else.

Enhanced mind-body
connection:
VMT music experiences
and psychoeducation
help participants gain
greater awareness of the
impact of emotional and
cognitive state on their
pain management

And I think most of the benefit that I got directly from the
sessions themselves was probably for me more related to
emotional issues related with pain.

If you don’t understand your feelings, how do you expect
anyone else to? [.] this music program will help you
learn to get to know yourself. Then, other things will
follow.

When you sing, it release endorphins, so it helps to lift the
mood and better manage the pain.

(continued)

118

Integration of quantitative and qualitative findings

Participants’ reports of using music-based pain manage-
ment strategies at home aligned with the large treatment
effect for self-efficacy as the self-efficacy questionnaire
measured participants’ beliefs that they are able to control
their pain and use methods other than medication for pain
relief. Given this finding, the small improvement in pain
interference was surprising, especially since the 8-week VMT
program resulted in a moderate effect size for this outcome.

8

As for psychosocial outcomes, participants shared that they
had learned to use music to address emotions that worsen
their pain and that the VMT program had helped to develop
stronger connections with others. This was supported by the
large treatment effects for depression and participation in
social activities (i.e., ability to do things with others).

The lack of improvement in satisfaction with social roles
and activities (i.e., being able to do things for family and
friends) is explained by the qualitative findings: participants
stated that the VMT program had empowered them to set

boundaries with friends and family and prioritize self-care,
thus suggesting that ‘‘being able to do things for others’’
may not have been a desirable outcome for study partici-
pants. This makes sense given that this study included many
low-income residents with complex family situations and
high caregiver burden. Participants shared in the interviews
that self-care involves being selective with their effort in
taking care of other people.

Discussion

The purpose of this study was to determine the feasibility
and preliminary effects of a 12-week VMT program on
chronic pain management. Despite suggestions from par-
ticipants in a prior study of an 8-week version of the VMT
protocol to increase program length to 12 weeks,

8
the con-

sent rate for this study (56%) was much lower than that
obtained in the 8-week VMT study (77%). The fact that the
attrition rate in this study (23%) was lower compared with

Table 5. (Continued)

Themes and definitions Categories and definitions Example quotes

Managing emotions:
Participants learned
music-based strategies
to decrease, work
through, and tolerate
stressful and emotional
situations.

But it really showed me how if you really take the time,
music can really help with certain areas of pain. It didn’t
take away the pain completely, but I do have issues with
PTSD and anxiety and things, and I get frustrated a lot,
especially with the pain. So it taught me how to just take
that time and take a moment.

When the therapist had us doing the humming and the
singing, it made you feel at peace.

Theme 3 Developing
meaningful connections:
The VMT program
promotes social,
cultural, and spiritual
connections

Universal connection:
music experiences
promote deeper
connections with
spiritual and
metaphysical entities.

Well, it (music) is a gift from God. And God shows you
some of things that they’re (peers) going through even
though you might have been through it all ready, but that
showed them how you can come out you strong. So it was
a touching.it (music) was like a ministry thing to
me.you know, within myself.

Th

need help revising my evidence based guidelines article review

Vocal Music Therapy for Chronic Pain:
A Mixed Methods Feasibility Study

Ming Yuan Low, MA, MT-BC,1 Clarissa Lacson, MA, MT-BC,1 Fengqing Zhang, PhD,2

Amy Kesslick, MA, MT-BC, LPC,3 and Joke Bradt, PhD, MT-BC1

Abstract

Objective: The purpose of this study was to determine the feasibility and preliminary effects of a vocal music
therapy (VMT) program on chronic pain management.

Design: A mixed methods intervention design was used in which qualitative data were embedded within a
randomized controlled trial.

Setting: An urban nurse-management health center on the East Coast of the United States.
Subjects: Participants (N = 43) were predominantly Black (79%) and female (76.7%) with an average pain

duration of 10 years.
Intervention: Participants were randomly allocated to a 12-week VMT program or a waitlist control.
Outcome measures: We tracked consent rate (percentage of participants enrolled out of total number

screened), attrition rate, and treatment adherence. We used PROMIS

(Patient Reported Outcomes Measure-
ment Information System) tools to measure pain interference, pain-related self-efficacy, pain intensity, de-
pression, anxiety, positive effect, and well-being, ability to participate in social activities, and satisfaction with
social roles at baseline and week 12. VMT participants also completed the Patient Global Impression of Change
Scale. We conducted semistructured interviews to better understand participants’ experience of the intervention.

Results: The consent rate was 56%. The attrition rate was 23%. Large treatment effects (partial eta squared) were
obtained for self-efficacy (0.20), depression (0.26), and ability to participate in social activities (0.24). Medium effects
were found for pain intensity (0.10), anxiety (0.06), positive effect, and well-being (0.06), and small effects for pain
interference (0.03) and satisfaction with social roles (0.03). On average, participants felt moderately better after
completion of the VMT program (M = 4.93, standard deviation = 1.98). Qualitative findings suggest that VMT resulted
in better self-management of pain, enhanced psychological well-being, and stronger social and spiritual connections.

Conclusions: Recruitment into the 12-week program was challenging, but quantitative and qualitative
findings suggest significant benefits of VMT for chronic pain management.

Keywords: music therapy, pain management, clinical trials

Introduction

Chronic pain is a significant public health problemamounting to an annual health care expense of ap-
proximately half a trillion dollars in the United States

alone.
1

In 2016, the Centers for Disease Control and
Prevention issued recommendations to move away from
opioids and instead use nonpharmacological thera-
pies for the treatment of chronic pain.

2
The use of music

for the management of chronic pain is increasingly

Departments of 1Creative Arts Therapies and 2Psychology, Drexel University, Philadelphia, PA.
3Stephen and Sandra Sheller 11th Street Family Health Services, Drexel University, Philadelphia, PA.

ª Ming Yuan Low, et al. 2019; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms
of the Creative Commons Attribution Noncommercial License (http://creativecommons.org/licenses/by-nc/4.0/) which
permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the
source are cited.

THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE

JACMVolume 26, Number 2, 2020, pp. 113–122Mary Ann Liebert, Inc.
DOI: 10.1089/acm.2019.0249

113

gaining interest, but more efficacy research is needed to
encourage health care providers to recommend its use to
patients.

3,4

To date, research on the use of music for pain has focused
primarily on listening to prerecorded music for acute pain
management with reported treatment benefits for reducing
pain intensity and opioid requirements.

5,6
A recent review

3

on the impact of music on chronic pain reported a moderate
effect size for pain (standardized mean difference = 0.60),
but results were inconsistent across studies (I

2 = 60%). The
majority of the studies (11/14) in this review employed
listening to prerecorded music; one study used choir singing,
and two studies used listening to live music.

The pain-reducing effects of music are often attributed to
music’s ability to distract and relax. However, chronic pain
is a complex phenomenon that affects individuals physi-
cally, mentally, socially, and spiritually and its management,
therefore, requires interventions that go beyond cognitive
distraction.

7
Therefore, we developed a vocal music therapy

(VMT) treatment program that addresses biopsychosocial
components of chronic pain management.

8

Music therapy is the clinical use of music interventions to
help clients optimize their health within a therapeutic rela-
tionship with a board-certified music therapist.

9,10
The VMT

group sessions use toning (i.e., singing of elongated vowels)
and humming, music-guided breathing, group singing, vocal
improvisations, verbal processing of emotions and thoughts
evoked by the music experiences, as well as psychoeduca-
tion about how music can address biopsychosocial factors
that impact chronic pain management. We briefly summa-
rize here the intervention’s theoretical framework, but
readers are referred to Bradt et al.

8
for a more in-depth

discussion.
On a bioneurological level, music listening and music

making activate brain areas involved with reward, emo-
tion, and arousal such as the nucleus accumbens, amygdala,
anterior insula, cingulate cortex, orbitofrontal cortex, and
mediodorsal thalamus, through which affective and cogni-
tive modulation of pain can be achieved.

11–13
On a psycho-

logical level, toning and humming are used to help enhance
body awareness, promote a positive connection with one’s
body, and facilitate relaxation. Since people with chronic
pain often try to disconnect from their body to ‘‘escape’’
the pain, these are considered important mechanisms in
chronic pain management.

14

Singing and active music making also help facilitate
emotional expression; emotional expressivity has been
shown to improve a sense of well-being and self-reliance in
people with chronic pain.

15
Finally, group music making

facilitates social inclusion and a sense of belonging.
16,17

Because people with chronic pain often feel isolated, this is
an important aspect of the VMT group.

The VMT program was initially tested as an 8-week
program.

8
Study findings were promising with large and

moderate effect sizes for pain-related self-efficacy and
pain interference, respectively, but participants unanimously
agreed that a longer program was desirable. Yet, concerns
were raised by health care providers at the study site about
the feasibility to recruit people with chronic pain to a
lengthier program. Therefore, the purpose of this mixed
methods feasibility study was to (1) determine the feasibility
of a 12-week VMT protocol; (2) provide estimates of effect

for core outcomes in chronic pain management; and (3)
obtain qualitative data about participant experiences of the
VMT program.

Materials and Methods

Study design

We employed a mixed methods intervention design,
18

in
which qualitative data (i.e., semistructured interviews) were
embedded within a randomized controlled trial. Participants
were randomized to the VMT or waitlist control (WLC)
treatment arm using a computer-generated list of random
numbers. Allocation concealment was achieved through the
use of sequentially numbered, opaque, sealed envelopes.
Since self-report measures were used for all outcomes, out-
come assessment could not be blinded as participants were
aware of their treatment allocation. However, the statistician
was blinded to group assignments (Fig. 1).

Participants

Participants were recruited from an urban nurse-managed
health center that predominantly serves inner-city, low-
income African Americans. Eligibility criteria are included
in Table 1. Participant demographic and clinical character-
istics at baseline are presented in Table 2. The majority of
the participants were female (76.7%), were black (79%),
were on disability leave (60.5%), and had an average pain
duration of 10 years. No significant between-group differ-
ences were present at baseline. The study was approved by
an Institutional Review Board. Informed consent was ob-
tained from all participants. We recruited participants in
three waves. In each wave, participants were randomly as-
signed to VMT or WLC. WLC participants were invited to
participate in the VMT intervention after completion of the
outcome measures at the end of the waitlist period.

Interventions

Vocal music therapy. Participants in the VMT treatment
program received twelve 90-min weekly group therapy
sessions (four to six participants). Sessions were led by a
board-certified music therapist. The VMT sessions followed
a similar structure, but were each focused on a different
topic related to music-based pain management (Table 3).

After a brief music-guided deep breathing exercise and
verbal check-in, the music therapist led the participants into
toning (i.e., singing elongated vowels) and humming expe-
riences. Using the voice in this manner can help facilitate
greater body awareness and promote relaxation. The group
then talked about somatic sensations experienced during the
breathing and toning exercises.

The session then moved into vocal music improvisations.
Percussion instruments were often added, resulting in en-
ergetic music making. These improvisations provided op-
portunities for emotional expression. Furthermore, group
music making enabled participants to relate to others and
share some of their struggles in novel ways. Verbal pro-
cessing after the improvisation often evolved into additional
improvisations focused on the main ideas of the group
discussion.

Throughout the sessions, psychoeducation was pro-
vided about how music can address biological (e.g., music

114 LOW ET AL.

stimulates dopaminergic activity resulting in improved
mood), psychological (e.g., song lyrics can help validate
one’s feelings), and social (e.g., group music making creates
a sense of belonging) factors that play an important role in
chronic pain management. Education about why and how
music can address pain management can help with trans-
ferability of skills and knowledge outside of the session
room and equips participants to explain to family and
friends how music-based self-management techniques help
them with their pain.

Each session ended with singing a song listed by one of
the group members during intake. Participants were asked to
underline a lyric that was particularly meaningful to them
and could possibly be a source of emotional support during
the week. The therapist then facilitated a discussion about
the meaning of the selected lyrics.

8
The music therapist was

trained by J.B. using a treatment manual. Each session was
recorded and reviewed by J.B. to ensure treatment fidelity.

The original protocol tested in a previous study consisted
of eight 60-min sessions. The 12-week protocol was very
similar to the 8-week protocol, except that (1) the longer

session length allowed for more time for each music expe-
rience and group processing and (2) the longer program
length allowed for review sessions to revisit insights and
music-based pain management skills gained. The VMT
treatment manual will be published in the near future.

Waitlist control. Participants in the WLC group received
care as usual at the health center. At the center, chronic pain
management typically consists of pharmacological treat-
ment and physical therapy services. Additional comple-
mentary services are available, including yoga and fitness
classes.

Outcome measures

To determine feasibility, we tracked the following: (1)
consent rate (percentage of participants enrolled out of total
number screened); (2) attrition rate; and (3) treatment com-
pliance (number of sessions attended). To measure the ef-
fects of the intervention, we used the Patient Reported
Outcomes Measurement Information System (PROMIS


)
19

short forms (SF) to measure pain interference (SF-6b),
pain-related self-efficacy (SF-6), pain intensity (SF-3a),
depression (SF-4a), anxiety (SF-4a), positive effect, and
well-being (SF), ability to participate in social activities (SF-
4a), and satisfaction with social roles and activities (SF-4a).
Finally, participants rated their perception of improvement
using the Patient Global Impression of Change Scale (PGIC).

20

Measurements were administered at baseline and week 12.
After completion of the week 12 measurements, participants
(including WLC participants who opted to receive VMT after
the WLC period) were invited to participate in a semi-
structured interview aimed at better understanding their ex-
perience of the intervention (Appendix 1). Measurements and
interviews were administered by research assistants.

FIG. 1. Participant flow chart.

Table 1. Study Eligibility Criteria

Inclusion criteria Exclusion criteria

English-speaking
adults

Moderate to profound auditory
deficits

Age 18 or older Severe progressive medical or
neurological comorbidities

Chronic pain
for ‡3 months

Severe psychiatric disorder

Pain impact score
of ‡27 (moderate
impact)

a

Cognitive impairment
Current alcohol or drug problem
Currently receiving music therapy

services

a
Impact score items derived from Deyo et al.

35

VOCAL MUSIC THERAPY FOR CHRONIC PAIN 115

Data analysis

Quantitative data. For each of the outcome variables, we
compared the average difference between the VMT and WLC
conditions in improvements of the outcome from baseline to
week 12. T-scores were used for all PROMIS tools.

21
Raw

scores were used for the PGIC. Due to the small sample size,
mean difference of improvement from baseline to week 12
between the two conditions and the 95% confidence interval
(CI) was reported and used for inference. In addition, we
compared the improvement in the outcomes between the two
conditions controlling for baseline values. Partial eta squared
from ANCOVA was used to quantify the effect size and

was interpreted as small (0.01), moderate (0.06), and large
(0.14).

22,23
Given the limited sample size, we based our in-

ference on effect sizes.
24,25

Qualitative data. The transcripts of the interviews were
imported into MAXQDA 11

26
and analyzed by two coders

( M.Y.L. and C.L.) to ensure scientific rigor. We used the-
oretical thematic analysis procedures as outlined by Braun
and Clarke.

27
Coding was based on a semantic approach in

which codes are derived from ‘‘the explicit meaning of the
data and the analyst is not looking for anything beyond what
a participant has said’’

27
(p. 84). After codes were agreed

upon by both coders, they were organized into categories.
These were presented to J.B. for input and were compared
against the text excerpts associated with the codes for ver-
ification. The categories were then organized into broader
themes. After final categories and themes were agreed upon,
definitions for the categories and themes were developed.

Results

Feasibility

The consent rate was 56%. Of the 43 participants who
completed the baseline, 33 completed the postintervention
measures. This represents an attrition rate of 23% (Fig. 1).
Of the VMT participants, nine participants attended nine or
more sessions. Failure to attend a session was mainly due to
childcare issues, family emergencies, bad weather, health
issues, and traveling.

Preliminary efficacy

Table 3 details the mean change scores (baseline to week
12) and standard deviations (SDs) for each group as well as

Table 2. Sociodemographic and Clinical Characteristics of Study Participants at Baseline

Characteristic Music therapy (n = 22) Waitlist control (n = 21) p

Age, years, mean (SD) 48.76 (9.95) 51.38 (16.87) 0.12
Gender, female, n (%) 16 (72.73) 17 (80.95) 0.45
Race, n (%) 0.20

Black 18 (81.82) 16 (76.19)
Caucasian 3 (13.64) 0 (0)
Asian 1 (4.5) 0 (0)
American Indian or Alaska Native 0 (0) 1 (4.8)
Multiracial 0 (0) 4 (19.05)

Employment, n (%) 1.0
Employed 3 (13.63) 2 (9.52)
Unemployed 4 (18.18) 3 (14.29)
Retired 1 (4.5) 2 (9.52)
On disability 13 (59.1) 13 (61.9)

Duration of pain, years, mean (SD) 9.43 (7.02) 10.43 (11.13) 0.68
Pain diagnosis,

a
n (%) 0.71

Arthritis 8 (36.36) 10 (47.62)
Degenerative disc/spinal stenosis 2 (9.09) 3 (14.29)
Neuropathy 3 (13.63) 1 (4.76)
Fibromyalgia 2 (9.09) 2 (9.52)

Pain impact score 37.40 (6.64) 39.19 (6.39) 0.36
Prior music performance experience,

b
n (%) 0.75

Yes 13 (59.1) 11 (52.38)
No 8 (38.10) 10 (47.62)

a
Most commonly reported pain diagnoses.

b
Having played an instrument or sung in a choir.

SD, standard deviation.

Table 3. Session Topics

Session
number Session topic

1 Introduction and rapport building
2 Music making to enhance body awareness
3 Music-based techniques to promote self-care

and acceptance
4 Music-based self-management of pain and stress
5 Music as motivator for physical activity
6 Review session: Review skills learned/insights

gained to date
7 Music as a source of strength and inspiration
8 Emotional expressivity through music
9 Enhancing social support through music

10 Music as source of empowerment
11 Develop plan for maintenance of music-based

skills
12 Closure session

116 LOW ET AL.

the effect sizes. There was a large treatment effect of VMT
for pain-related self-efficacy, depression, and ability to par-
ticipate in social activities. The 95% CIs associated with
these large effect sizes suggest that these findings were sta-
tistically significant. Medium treatment effects were found
for pain intensity, anxiety, and positive affect and well-
being, and small effect sizes for pain interference and sat-
isfaction with social roles. The 95% CIs of these medium
and small effect sizes suggest that these were not statisti-
cally significant. On average, PGIC scores (M = 4.93, SD =
1.98) suggest that participants felt moderately better after
completion of the VMT program (Table 4).

Qualitative results

A total of 25 participants took part in the semistructured
interviews. All participants reported that the VMT sessions
were beneficial in helping them manage their pain inside
and outside of sessions (Theme 1, Pain Management). One
participant remarked, ‘‘Every time I play the instruments, it
helped me with my pain [.] That drum playing changed
my pain in some kinda way. ‘Cuz I didn’t have it [pain] once
I stopped doing the drums.’’ Participants shared that they
used VMT strategies to assist them with their daily activities
and chores or for motivation in the morning: ‘‘I wasn’t
feeling too good this morning. I turned on some music and it
took my mind off of that feeling. I was able to get dressed on
time and I made it here on time.’’

Some participants reported using music-based skills as al-
ternatives to their pain medication as the music helped to soothe
the pain and refocus their attention. Other participants stated
that the music made their pain ‘‘go away’’: ‘‘That day I was
having a lot of pain. We started singing and [.] it just went
away.’’ One person commented how purposefully music lis-
tening helped them with daily activities: ‘‘There are certain
songs I like, I can get into the rhythm of them. I just focus on the
music part, and it gave me a rhythm. As long as I was listening
to the music when I was working, I was able to keep going.’’

Many participants reported enhanced psychological well-
being in response to the VMT experiences and the psy-
choeducation about how music can address different factors
that influence their pain (Theme 2, Improved Psychological
Well-being). Participants shared that the VMT program led

to (1) better understanding of the contribution of stress and
other emotions to their pain, (2) greater awareness of the
presence of stress and uncomfortable emotions, and (3)
learning new music-based skills to help deal with mental
states that exacerbated their pain. One participant shared the
following: ‘‘I have step-children that I take care of. It can
become overwhelming. [Music] helps me just take that
moment to woosh (sic) and [.] release that negativity so
they don’t see that and feel that.’’

Some participants told us that they are now more inten-
tional with their use of music and that they create playlists
for specific purposes. Participants also emphasized that
learning to be kinder to oneself, achieving mindfulness, and
understanding who they are were important skills gained from
the program. One person shared that ‘‘keeps you away from
that self-blame—because that [self-blame] adds to the pain.’’
A large number of comments referred to feeling empowered to
prioritize one’s mental health and physical needs over de-
mands by others and seeking out things in life that bring joy.
Participants also appreciated that attending the program was a
form of self-care as expressed by one participant: ‘‘It made me
feel like I’m doing something for myself.’’

The third and final theme (Developing Meaningful Con-
nections) relates to music aiding in facilitating deeper
connections with one’s spirituality and stronger bonds with
others. One participant commented, ‘‘The spiritual aspect of
music and the emotional feelings that I got from just beating on
the drum, or playing the tambourine, or that ocean drum!’’

Many participants reminisced fondly about the bonds
among the group members that were created through the
VMT program. One participant said, ‘‘It was wonderful
because the group started out with everybody was in their
little shell. [.] And on the recording [excerpts from ses-
sions] that we heard after the group, we just heard our story,
and like how amazing how everybody developed. And we
became united. We became a family.’’ Another participant
appreciated the accepting and nonjudgmental environment
the group provided, ‘‘With friends or family or romantic
partners or even doctors, sometimes struggling so much to
explain intermittent, invisible chronic pain to the point of
disability [.] Hearing and being understood and sharing
just felt really comfortable and in a way that I had not ex-
perienced.’’ Participants shared that these bonds continued
outside of the sessions (Table 5).

Table 4. Change in T-Scores, Mean Difference and Effect Size

Outcome

Change score (SD)
a

MD (95% CI)
b

Effect size (Zp
2
)VMT WLC

Pain-related self-efficacy 4.84 (5.14) -0.26 (4.76) 5.10 (1.52 to 8.68) 0.20
Pain interference -2.46 (5.06) -0.45 (3.52) -2.01 (-5.17 to 1.15) 0.03
Pain intensity -5.7 (7.24) -1.86 (4.47) -3.85 (-8.19 to 0.49) 0.10
Anxiety -2.42 (8.55) 0.39 (7.32) -2.82 (-8.56 to 2.94) 0.06
Depression -4.92 (4.83) 2.56 (7.99) -7.48 (-12.25 to -2.71) 0.26
Positive affect and well-being 0.14 (6.8) -2.22 (5.96) 2.36 (-2.27 to 6.98) 0.06
Ability to participate in social activities 2.26 (3.62) -2.55 (6.53) 4.81 (0.99 to 8.62) 0.24
Satisfaction with social roles 1.59 (5.82) -0.51 (6.86) 2.10 (-2.49 to 6.70) 0.03

a
change from baseline to week 12.

b
Ninety-five percent CI intervals that do not include the value zero suggest that the findings are statistically significant.
Zp

2
, partial eta squared based on ANCOVA.

CI, confidence interval; MD, mean difference; SD, standard deviation; VMT, vocal music therapy; WLC, waitlist control.

VOCAL MUSIC THERAPY FOR CHRONIC PAIN 117

Table 5. Qualitative Findings

Themes and definitions Categories and definitions Example quotes

Theme 1 Pain
management:
The VMT program
offers participants
strategies to manage
pain in their daily lives.

Enhanced physical
functioning:
Music engagement helps
to improve activity
levels and ability to do
chores

But I use the soft jazz just to help with. I just sit there and
listen to it and I close my eyes. And I just rub my knees
[.] and when I feel like the feeling is going to be okay
and I can get up and not have a limp or anything, I get
up. And then, I don’t have no limp. The knee don’t be
bothering me.

I use to could not even walk 2 or 3 blocks. I would have to
like really sit down and take a breather. But it just seemed
like once I came here [.] and we just got into the
mood.once everything was over, I’d go home and I’m
like ‘‘I’m not in no pain at all.’’ And I never realize it and
I’m like doing all this stuff (chores) in the house.

Reducing pain:
Music brings pain relief
through its soothing
qualities as well as
through refocusing of
attention

I would describe it [the music] as a de-stressor. A way to
rethink, recharge your mind in a different direction and
also to take your mind off the pain.I’m not going to say
it can totally go away but it’ll subside a little to a point
where you’re functional.

I liked the ocean drum. That is really soothing, and it just
relaxed my whole body. I just listened to the sound of it, and
it takes you to sitting on the beach (in your imagination) and
just watching the waves. It was really peaceful.

When the pain begins to come, I try to hum [.] just direct
my attention to something else.

Theme 2 Improved
psychological well-
being:
VMT strategies help
manage difficult
psychological and
emotional states that
contribute to pain.

Achieving mindfulness:
Music helps participants
be more present by
creating a relaxed and
clearer state of mind.

A lot of the music that we’ve used were meditative, so it
kind of allows me to broaden like, my mind and my
perception.with sounds.

I do music for de-stress. And to take my mind off the
pain.it’s like a rethinking process. mindfulness. So
when I’m mindful, first I do mindful exercises and
breathing. Recognizing my own breath. My own
heartbeat. And it tends to calm down.

Empowerment:
VMT empowers
participants to prioritize
self-care, helps to
restore hope, and
motivates to be active.

And there’s this sign of hope. That’s what I liked about the
songs.that they’re sign of hope, they’re sign of
welcoming.

It helps your day to keep going. [.] you look over at the
other person, and you see that their struggles might be a
little different than yours. But you see how they push
through it. So to me, it makes me push through it even
more because I’m like, ‘‘Okay, you know.I’m gonna
keep going.’’

Also, just learning patience with my pain and being kinder
to my body about it. In the sense of, you know, I feel like
for a long time it was mostly just being mad and having
that energy toward whatever part of my body was not
feeling good or what I couldn’t do, so I think a lot of what
I took from that was, you know, focusing on what I can do
now, what I can do to help myself, and something like
that. Yeah. I do have, I have a lot more now.

You were allowed to sing lousy or you were allowed to be
off key. [.] In the group it just didn’t matter. I watched
people’s volume—as their confidence level went up, their
volume increased. Their voices were being heard.

The songs that we would sing, it really was so motivating.
I felt like I was somewhere else.

Enhanced mind-body
connection:
VMT music experiences
and psychoeducation
help participants gain
greater awareness of the
impact of emotional and
cognitive state on their
pain management

And I think most of the benefit that I got directly from the
sessions themselves was probably for me more related to
emotional issues related with pain.

If you don’t understand your feelings, how do you expect
anyone else to? [.] this music program will help you
learn to get to know yourself. Then, other things will
follow.

When you sing, it release endorphins, so it helps to lift the
mood and better manage the pain.

(continued)

118

Integration of quantitative and qualitative findings

Participants’ reports of using music-based pain manage-
ment strategies at home aligned with the large treatment
effect for self-efficacy as the self-efficacy questionnaire
measured participants’ beliefs that they are able to control
their pain and use methods other than medication for pain
relief. Given this finding, the small improvement in pain
interference was surprising, especially since the 8-week VMT
program resulted in a moderate effect size for this outcome.

8

As for psychosocial outcomes, participants shared that they
had learned to use music to address emotions that worsen
their pain and that the VMT program had helped to develop
stronger connections with others. This was supported by the
large treatment effects for depression and participation in
social activities (i.e., ability to do things with others).

The lack of improvement in satisfaction with social roles
and activities (i.e., being able to do things for family and
friends) is explained by the qualitative findings: participants
stated that the VMT program had empowered them to set

boundaries with friends and family and prioritize self-care,
thus suggesting that ‘‘being able to do things for others’’
may not have been a desirable outcome for study partici-
pants. This makes sense given that this study included many
low-income residents with complex family situations and
high caregiver burden. Participants shared in the interviews
that self-care involves being selective with their effort in
taking care of other people.

Discussion

The purpose of this study was to determine the feasibility
and preliminary effects of a 12-week VMT program on
chronic pain management. Despite suggestions from par-
ticipants in a prior study of an 8-week version of the VMT
protocol to increase program length to 12 weeks,

8
the con-

sent rate for this study (56%) was much lower than that
obtained in the 8-week VMT study (77%). The fact that the
attrition rate in this study (23%) was lower compared with

Table 5. (Continued)

Themes and definitions Categories and definitions Example quotes

Managing emotions:
Participants learned
music-based strategies
to decrease, work
through, and tolerate
stressful and emotional
situations.

But it really showed me how if you really take the time,
music can really help with certain areas of pain. It didn’t
take away the pain completely, but I do have issues with
PTSD and anxiety and things, and I get frustrated a lot,
especially with the pain. So it taught me how to just take
that time and take a moment.

When the therapist had us doing the humming and the
singing, it made you feel at peace.

Theme 3 Developing
meaningful connections:
The VMT program
promotes social,
cultural, and spiritual
connections

Universal connection:
music experiences
promote deeper
connections with
spiritual and
metaphysical entities.

Well, it (music) is a gift from God. And God shows you
some of things that they’re (peers) going through even
though you might have been through it all ready, but that
showed them how you can come out you strong. So it was
a touching.it (music) was like a ministry thing to
me.you know, within myself.

Th